Breast pump systems

ABSTRACT

Systems and methods for pumping milk from a breast responsive to a controller, wherein the milk is expressed from the breast under suction and milk is expulsed from the pumping mechanism to a collection container under positive pressure.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to portable, energy efficientbreast pump systems and methods for collecting milk from a breast of anursing mother.

BACKGROUND OF THE DISCLOSURE

As more women become aware that breastfeeding is the best source ofnutrition for a baby, and also offers health benefits to the nursingmother, the need is increasing for breast pump solutions that areuser-friendly, quiet, discrete and versatile for use by a nursing motherin various situations. This is particularly true for the working mother,who is away from the home for eight to ten hours or more and needs topump breast milk in order to have it available for her baby, but it isalso a requirement for many other situations where the mother is awayfrom the privacy of the home for an extended period, such as duringshopping, going out to dinner or other activities.

Although a variety of breast pumps are available, most are awkward andcumbersome, requiring many parts and assemblies and being difficult totransport. Hand pump varieties that are manually driven are onerous touse and can be painful to use. Some powered breast pumps require an ACpower source to plug into during use. Some systems are battery driven,but draw down the battery power fairly rapidly as the motorized pumpcontinuously operates to maintain suction during the milk extractionprocess. Many of the breast pumps available are clearly visible to anobserver when the mother is using it, and many also expose the breast ofthe mother during use.

There is a continuing need for a small, portable, self-powered, energyefficient, wearable breast pump system that is easy to use and isdiscrete by not exposing the breast of the user and being invisible ornearly unnoticeable when worn.

To ensure that the nursing baby is receiving adequate nutrition, it isuseful to monitor the baby’s intake. It would be desirable to provide abreast pump system that easily and accurately monitors the volume ofmilk pumped by the system, to make it convenient for the nursing motherto know how much milk has been extracted by breast pumping. It wouldalso be desirable to track milk volume pumped per session, so that thevolume of milk contained in any particular milk collection container canbe readily known.

Many existing breast pump systems can cause considerable discomfort tothe user over time. One cause of such discomfort is chafing of thenipple against the nipple flange/housing as the nipple stretches andcontracts during the pumping session. There is a continuing need for abreast pump system that is more comfortable to the user, even overrepeated pumping sessions.

SUMMARY OF THE DISCLOSURE

Briefly and in general terms, the present disclosure is directed towardbreast pump systems or methods. The system includes breast contactingstructure and a storage container, and structure that delivers milk froma breast to the storage container. The method involves pumping milk froma breast and delivering the pumped milk into the storage container.

According to one aspect of the present disclosure, a system for pumpingmilk from a breast includes one or more of: a skin contact memberconfigured to form a seal with the breast; a conduit in fluidcommunication with and connected to the skin contact member; a drivingmechanism configured to establish a vacuum profile within the conduit;an external shell; and a milk collection container; wherein the externalshell comprises a compartment facing a distal end of the external shell,the external shell further comprising a proximal end surface facing awayfrom the proximal end; wherein the skin contact member, the conduit andthe driving mechanism are received in the compartment of the externalshell; wherein the milk collection container is positionable over thedistal end surface of the shell; and wherein the system is shaped andconfigured to be contoured to the breast of a user.

In various of the disclosed embodiments, the system defines a naturalbreast profile. The natural breast profile is contemplated to fitcomfortably and conveniently into a bra of a user and to present anatural look. As such, the profile is characterized by having anon-circular base. Moreover, like natural breasts, the profile of thedevice or system is contemplated to define one or more asymmetric curvesand off-center inertial centers.

In at least one embodiment, the skin contact member, the conduit, thedriving mechanism, the external shell and the milk collection containerare all contained within a cup of a brassiere.

In at least one embodiment, the system is battery powered, the systemcomprising a battery, wherein the battery is received in the compartmentof the external shell.

In at least one embodiment, the proximal surface of the external shellis shaped and configured to be contoured to the breast of a user and tothus provide a more natural appearance when under clothing worn by theuser.

In at least one embodiment, the proximal surface of the external shellcomprises a polygonal, flat, irregular or discontinuously curved shapedissimilar to the curvature of the breast; and the milk collectioncontainer is configured to interface with the proximal surface and to beshaped and configured to be contoured to the breast of a user and tothus provide a more natural appearance when under the clothing of theuser.

In at least one embodiment, the proximal surface comprises flat surfacesthat form an angular external surface.

In at least one embodiment, the proximal surface comprises a flatcentral portion and convex portions extending radially from the flatcentral portion.

In at least one embodiment, the milk collection container is configuredand dimensioned to have variable volume when filled, so as to conform tothe proximal surface of the external shell as the milk collectioncontainer is being filled with milk, while providing a convex shapeexternally, so as to mimic a natural shape of the breast.

In at least one embodiment, the milk collection container is pre-shapedto follow contours of the proximal surface of the external shell and toproviding a convex shape externally, so as to mimic a natural shape ofthe breast.

In at least one embodiment, the milk collection container comprises arigid distal surface that mates with contours of the proximal surface ofthe external shell, and a flexible proximal surface that moves as milkenters the milk collection container, to provide a convex shape thatmimics a natural shape of the breast.

In at least one embodiment, the milk collection container comprises aflexible distal surface that changes shape to mate with contours of theproximal surface of the external shell as milk enters the milkcollection container, the milk collection container further comprising arigid proximal surface that provides a convex shape that mimics anatural shape of the breast.

In at least one embodiment, the milk collection container comprises arigid distal surface pre-shaped to mate with contours of the proximalsurface of the external shell as milk enters the milk collectioncontainer.

In at least one embodiment, the milk collection container comprises atleast one structural element configured to restrict an amount ofexpansion of the milk collection container or provide shape to the milkcollection container even when empty.

In at least one embodiment, the at least one structural element isselected from the group consisting of baffles, heat seals, struts andrestrictions.

In at least one embodiment, the milk collection container comprises aunique identifier configured to be read by a computer processor and thatuniquely distinguished the milk collection container from all other milkcollection containers.

In at least one embodiment, the unique identifier comprises a sensor.

In at least one embodiment, the sensor comprises a passive sensor.

In at least one embodiment, the system further includes a controllerpositioned within the external shell and configured to controloperations of the driving mechanism.

In at least one embodiment, the milk collection container comprises aunique identifier configured to be read by at least one of thecontroller and an external computer processor and that uniquelydistinguished the milk collection container from all other milkcollection containers.

In at least one embodiment, the unique identifier comprises a sensor.

In at least one embodiment, the sensor comprises a passive sensor.

In at least one embodiment, the sensor is selected from the groupconsisting of: RFID device, NFC device, Wi-Fi device, BLUETOOTH deviceand BLUETOOTH Low Energy (BTLE) device.

In at least one embodiment, the sensor is selected from the groupconsisting of: RFID devices and NFC devices.

In at least one embodiment, the milk collection container comprises aone-way valve that permits milk inflow into the milk collectioncontainer but prevents milk backflow from the milk collection containerto the conduit.

In at least one embodiment, the conduit is integral with the milkcollection container.

In at least one embodiment, the system further includes a contourelement; wherein the contour element extends distally from a distalperimeter of the external shell and proximally extends over a distalportion of the external shell to provide a contoured extension of theexternal shell that provides a visually more appealing appearance thatmore closely mimics a natural appearance of the breast supported by abra.

In at least one embodiment, the contour element tapers distally to forma smooth transition with the breast when the system is mounted on thebreast.

In at least one embodiment, the contour element is removably attached tothe external shell using at least one of snaps, hook-and-loop typefasteners, buttons, magnets adhesive, or friction fit.

In at least one embodiment, the contour element comprises a lateralportion that extends distally from the distal perimeter by a firstlength, and a medial portion that extends distally from the distalperimeter by a second length, wherein the first length is greater thanthe second length.

In at least one embodiment, the contour element is formed of lightweightmaterial comprising at least one of foam, plastic or fabric.

In at least one embodiment, the contour element is formed of a singlethin layer of plastic or fabric.

In at least one embodiment, the external shell comprises a key and thecontour element comprises a mating key; wherein the mating key mateswith the key when the contour element is mounted on the external shelland ensures that the contour element is positioned relative to theexternal shell consistently so that orientation of the contour elementrelative to the external shell upon successive mountings does not varyrotationally, superiorly, inferiorly, laterally or medially.

In at least one embodiment, the contour element is adjustable toaccommodate different breast sizes.

In at least one embodiment, the contour element comprises a first edgeand a second edge, wherein the first edge overlaps the second edge andcan be adjusted to reduce, increase or maintain a circumference of adistal perimeter of the contour element.

In at least one embodiment, the overlap of the first edge relative tothe second edge can be adjusted to reduce, increase or maintain acircumference of a proximal perimeter of the contour element.

In at least one embodiment, the contour element comprises a materialthat facilitates cutting a portion of a distal perimeter thereof fortailoring a fit of the contour element to the breast.

In at least one embodiment, the contour element comprises predeterminedmarkings to assist in adjusting the contour element to variouspredetermined sizes.

In at least one embodiment, the external shell comprises at least onekey and the contour element comprises multiple mating keys that matewith each the at least one key, respectively, to allow adjustment of asize of the contour element.

In at least one embodiment, the contour element is made of a resilientmaterial that conforms to a shape of an object that the contour elementis compressed against.

In at least one embodiment, the contour element is substantiallyflat-shaped in an unbiased configuration.

In at least one embodiment, the contour element is attachable to aproximal end portion of the external shell.

In at least one embodiment, the contour element, when supported by abra, contours to the external shell and the bra.

In at least one embodiment, the system further includes a valve in theconduit adjacent the skin contact member, wherein the valve isconfigured to open in a first direction when vacuum is generated in theconduit, to close when positive pressure up to a predetermined positivepressure is applied to the valve, and to open in a second direction whenpositive pressure exceeding the predetermined positive pressure isapplied to the valve.

According to another aspect of the present disclosure, a system forpumping milk from a breast includes one or more of: an external shellincluding a compartment facing a distal end of the external shell, theexternal shell further comprising a proximal end surface facing awayfrom the proximal end; the external shell carrying a self-containedpower source and a pump mechanism; a skin contact member supported bythe external shell; an outlet for expelling breast milk received fromthe breast interfaced with the skin contact member; and a milkcollection container in fluid communication with the outlet andpositioned against the distal end surface of the external shell; whereinthe system is shaped and configured to be contoured to the breast of auser.

In at least one embodiment, the system is contained within a cup of abrassiere.

In at least one embodiment, the skin contact member, the external shelland the milk collection container are sized and configured to besupported between the breast and a breast cup of a bra while the systemis actively pumping milk from the breast and expelling the milk throughthe outlet and into the milk collection container.

According to another aspect of the present disclosure, a milk collectioncontainer for use with a breast pump system includes one or more of: apreformed surface shaped to mimic the natural appearance of a breast;and a flexible surface opposing the preformed convex surface, theflexible surface being configured to expand as milk enters the milkcollection container.

In at least one embodiment, the milk collection container is mounted toan external surface of an external shell of a milk pump, wherein uponmilk entering the milk collection container, the flexible surface movesoutwardly and conforms to a conformation of the external shell.

In at least one embodiment, the milk collection container comprises atleast one structural element configured to restrict an amount ofexpansion of the milk collection container or provide shape to the milkcollection container even when empty.

In at least one embodiment, the at least one structural element isselected from the group consisting of baffles, heat seals, struts andrestrictions.

According to another aspect of the present disclosure, a system forpumping milk from a breast includes one or more of: a skin contactmember configured to form a seal with the breast; a conduit in fluidcommunication with and connected to the skin contact member; a drivingmechanism configured to establish a vacuum profile within the conduit bycyclically compressing and allowing decompression of a portion of theconduit; and an external shell containing the conduit and the drivingmechanism and supporting the skin contact member.

In at least one embodiment, the system further includes a milkcollection container, wherein the milk collection container is in fluidcommunication with the conduit.

In at least one embodiment, the milk collection container ispositionable over the distal end surface of the shell; and the system isshaped and configured to be contoured to the breast of a user.

In at least one embodiment, the skin contact member includes: a breastcontact portion configured and dimensioned to fit over a form a sealwith a portion of the breast; and a nipple receiving portion extendingfrom the breast contact portion.

In at least one embodiment, the nipple receiving portion comprises anon-tapering portion attached to the breast contact portion, and atapering portion extending from the non-tapering portion, the taperingportion configured and dimensioned to receive the nipple of the breast.

In at least one embodiment, the non-tapering portion is cylindrical andthe tapering portion is conical.

In at least one embodiment, the non-tapering portion is ovular orelliptical in cross section.

In at least one embodiment, the tapering portion is ovular or ellipticalin cross section.

In at least one embodiment, both the non-tapering and the taperingportions are ovular or elliptical in cross section.

In at least one embodiment, the breast contact portion comprises a firstcentral longitudinal axis and the nipple receiving portion comprises asecond central longitudinal axis; and the first and second centrallongitudinal axes are collinear.

In at least one embodiment, the breast contact portion comprises a firstcentral longitudinal axis and the nipple receiving portion comprises asecond central longitudinal axis; and the first and second centrallongitudinal axes are parallel.

In at least one embodiment, the breast contact portion comprises a firstcentral longitudinal axis and the nipple receiving portion comprises asecond central longitudinal axis; and the first and second centrallongitudinal axes intersect.

In at least one embodiment, a top part of the nipple receiving portionis configured to contact an upper surface of the nipple and a bottompart of the nipple receiving portion is configured to contact a lowersurface of the nipple; wherein the top part is formed a material havinga first hardness and the bottom part is formed of a material having asecond hardness; and wherein the first hardness is greater than thesecond hardness.

In at least one embodiment, the breast contact portion comprises atleast one region on an inner surface thereof, the at least one regionconfigured to contact the breast and provide friction thereagainst thatis greater than friction provided by a remainder of the inner surface ofthe breast contact portion.

In at least one embodiment, the system further includes a resilient flapextending radially inwardly from a portion of the breast contact member;wherein when the breast is inserted into the breast contact member, thebreast folds down the flap against an inner wall of the breast contactmember; and wherein when the breast is removed from the breast contactmember, the flap resiliently returns to an unbiased position and extendsradially inwardly, thereby retaining milk within the breast contactmember that would otherwise have spilled out of the breast contactmember.

In at least one embodiment, the flap comprises a tacky or roughenedsurface configured to increase friction against the breast whencontacting the breast.

In at least one embodiment, the system further includes a sensor mountedin or on the skin contact member or the conduit; and a controllerconfigured to control operation of the driving mechanism and to receivesignals from the sensor.

In at least one embodiment, the system further includes a first sensormounted in or on the skin contact member or the conduit, wherein athickness of the skin contact member or conduit at a location ofmounting the first sensor comprises a first thickness; and a secondsensor mounted in or on the skin contact member or the conduit, whereina thickness of the skin contact member or conduit at a location ofmounting the second sensor comprises a second thickness; wherein thesecond thickness is greater than the first thickness.

In at least one embodiment, the system further includes one or more of:a controller configured to control operation of the driving mechanism;and a switch in electrical communication with the controller, the switchextending into the skin contact member or the conduit at a distance froman inner wall of the skin contact member or the conduit predetermined asa distance by which the inner wall deflects when a predetermined vacuumpressure has been attained; wherein, upon attaining the predeterminedvacuum pressure, the switch is activated by contact with the inner walland sends a signal to the controller.

In at least one embodiment, the switch extends into the nipple receivingportion of the skin contact member.

According to another aspect of the present disclosure, a method ofoperating a system for pumping milk includes one or more of: providingthe system comprising a skin contact member configured to form a sealwith the breast, a conduit in fluid communication with and connected tothe skin contact member; a driving mechanism including a compressionmember configured to compress and allow decompression of the conduit inresponse to inward and outward movements of the compression member, asensor, and a controller configured to control operation of the drivingmechanism; sealing the skin contact member to the breast; operating thedriving mechanism to generate predetermined pressure cycles within theconduit; monitoring by the controller of at least one of position andspeed of movement of the compression member relative to the conduit;measuring or calculating pressure within the conduit; maintaining ormodifying motion of the compression member as needed, based uponfeedback from the calculated pressure and at least one of position andspeed of movement of the compression member, to ensure that thepredetermined pressure cycles continue to be generated.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, the method further including: manuallyadjusting a maximum suction pressure to modify the predeterminedpressure cycles.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, the method further including: purgingmilk from the conduit when the controller identifies that thecompression member has reached a location that is a predeterminedpercentage of a predetermined outward motion limit of the compressionmember relative to the conduit.

In at least one embodiment, the purging includes: controlling thecompression member by the controller to drive the compression member toa predetermined inward motion limit of the compression member therebydriving milk out of a portion of the conduit compressed by thecompression member.

In at least one embodiment, the method further includes controlling thecompression member to carry out the compression mode cycles afterperforming the purging.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the controller increases a strokedistance of the compression member relative to an amount of milkentering the conduit, to maintain predetermined pressures during theextraction mode pressure cycles.

In at least one embodiment, the predetermined pressure cycles compriselatch mode cycles, wherein upon determination that milk has entered theconduit or after a predetermined period of time, the controller operatesthe compression member to achieve predetermined extraction mode pressurecycles, wherein the predetermined extraction mode cycles differ from thepredetermined latch mode cycles by at least one of maximum suction levelor cycle frequency.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the method further includes:monitoring, by the controller, pressure waves within at least one of theconduit and the skin contact member; monitoring, by the controller, atleast one of position and speed of the compression member relative topressure levels monitored by the monitoring pressure waves; and changingat least one of speed, stroke length and position of the compressionmember when a predetermined amount of change in the monitored pressureversus monitored position or speed of the compression member isidentified, so as to maintain execution of the predetermined pressurecycles.

In at least one embodiment, the controller monitors positions of thecompression member; and wherein, upon detecting that the compressionmember has reached a location that is a predetermined percentage of apredetermined outward motion limit of the compression member relative tothe conduit, the controller controls the compression member to purgemilk from the conduit.

According to another aspect of the present disclosure, a system forpumping milk includes one or more of: a skin contact member configuredto form a seal with a breast; a conduit in fluid communication with andconnected to the skin contact member; a driving mechanism including acompression member configured to compress and allow decompression of theconduit in response to inward and outward movements of the compressionmember; a sensor; and a controller configured to control operation ofthe driving mechanism; wherein upon sealing the skin contact member tothe breast, the controller operates the driving mechanism to generatepredetermined pressure cycles within the conduit, monitors at least oneof position and speed of movement of the compression member relative tothe conduit, measures or calculates pressure within the conduit basedupon signals received from the sensor, and maintains or modifies motionof the compression member as needed, based upon feedback from thecalculated pressure and at least one of position and speed of movementof the compression member, to ensure that the predetermined pressurecycles continue to be generated.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the system is configured to allowmanual adjustment of a maximum suction pressure to modify thepredetermined pressure cycles.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the controller operates the drivingmechanism to purge milk from the conduit when the controller identifiesthat the compression member has reached a location that is apredetermined percentage of a predetermined outward motion limit of thecompression member relative to the conduit.

In at least one embodiment, the purging includes controlling thecompression member by the controller to drive the compression member toa predetermined inward motion limit of the compression member therebydriving milk out of a portion of the conduit compressed by thecompression member.

In at least one embodiment, the controller is further configured tocontrol the compression member to carry out the compression mode cyclesafter performing the purging.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the controller increases a strokedistance of the compression member relative to an amount of milkentering the conduit, to maintain predetermined pressures during theextraction mode pressure cycles.

In at least one embodiment, the predetermined pressure cycles compriselatch mode cycles and, upon determination that milk has entered theconduit or after a predetermined period of time, the controller operatesthe compression member to achieve predetermined extraction mode pressurecycles, wherein the predetermined extraction mode cycles differ from thepredetermined latch mode cycles by at least one of maximum suction levelor cycle frequency.

In at least one embodiment, the predetermined pressure cycles compriseextraction mode pressure cycles, and the controller is furtherconfigured to: monitor pressure waves within at least one of the conduitand the skin contact member; monitor at least one of position and speedof the compression member relative to pressure levels monitored by themonitoring pressure waves; and change at least one of speed, strokelength and position of the compression member when a predeterminedamount of change in the monitored pressure versus monitored position orspeed of the compression member is identified, so as to maintainexecution of the predetermined pressure cycles.

In at least one embodiment, the controller monitors positions of thecompression member and, upon detecting that the compression member hasreached a location that is a predetermined percentage of a predeterminedoutward motion limit of the compression member relative to the conduit,the controller controls the compression member to purge milk from theconduit.

According to another aspect of the present disclosure, a method ofpurging milk from a milk pumping system after completion of a milkextraction process includes one or more of: providing the systemcomprising a skin contact member configured to form a seal with thebreast, a conduit in fluid communication with and connected to the skincontact member; and a driving mechanism including a compression memberconfigured to compress and allow decompression of the conduit forpumping milk from a breast during the milk extraction process, whereinthe skin contact member is sealed to the breast during the milkextraction process; upon completion of the milk extraction process,reversing a direction the driving mechanism to operate in an oppositedirection to a direction of the driving mechanism executed to performthe milk extraction process, to decrease suction within the conduit;breaking the seal of the skin contact member with the breast; andreversing the direction of the driving mechanism again, after breakingthe seal, to the direction of the driving mechanism executed to performthe milk extraction process, thereby driving milk from the conduit.

In at least one embodiment, upon breaking the seal, the reversing thedirection of the driving mechanism again is initiated manually by anoperator.

In at least one embodiment, the system detects when the seal is brokenand automatically reverses the direction of the driving mechanism uponthe detection when the seal is broken.

In at least one embodiment, the method further includes ending thedriving milk from the conduit by ceasing operation of the drivingmechanism.

In at least one embodiment, the ending is initiated manually by anoperator.

In at least one embodiment, the system initiates the endingautomatically at a predetermined time after the reversing the directionof the driving mechanism again is initiated.

In at least one embodiment, the system initiates the endingautomatically, by measuring a compliance of the conduit and initiatingthe ending when the compliance reaches a predetermined compliance value.

In at least one embodiment, the reversing a direction of the drivingmechanism to decrease suction within the conduit comprises decreasingthe suction to greater than -20 mmHg.

In at least one embodiment, the reversing a direction of the drivingmechanism to decrease suction within the conduit comprises decreasingthe suction and establishing a slight positive pressure.

In at least one embodiment, the reversing a direction of the drivingmechanism to decrease suction within the conduit comprises decreasingthe suction to about 0 mmHg.

In at least one embodiment, the reversing a direction of the drivingmechanism to decrease suction within the conduit, comprises establishinga pressure in the conduit to a value in the range of from about -20 mmHGto about -50 mmHg.

According to another aspect of the present disclosure, a system forpumping milk includes one or more of: a pair of breast pumps, eachbreast pump comprising: a skin contact member configured to form a sealwith a breast; a conduit in fluid communication with and connected tothe skin contact member; a driving mechanism configured to establish avacuum profile within the conduit; a controller configured to controloperation of the driving mechanism; and means for indicating whether thebreast pump is attached to a left breast or a right breast, when both ofthe breast pumps are attached to the left and right breasts.

In at least one embodiment, each driving mechanism comprises acompression member configured to compress and allow decompression of theconduit in response to inward and outward movements of the compressionmember.

In at least one embodiment, the means for indicating is configured toreceive a signal by one of the breast pumps from the other of the breastpumps to establish relative locations of the breast pumps.

In at least one embodiment, each breast pump further comprises amagnetic coil, wherein a signal sent to one of the magnetic coils by thecontroller associated with the magnetic coil in one of the breast pumpsinduces a signal in the magnetic coil of the other of the breast pumps,the signal being interpretable by the controllers to identify relativepositioning of the breast pumps.

According to another aspect of the present disclosure, a system forpumping milk includes one or more of: a skin contact member configuredto form a seal with a breast; a conduit in fluid communication with andconnected to the skin contact member; a driving mechanism configured toestablish a vacuum in the conduit; and means for indicating an amount ofwear of at least one of the skin contact member and the conduit.

In at least one embodiment, the means for indicating comprises atime-based indicator.

In at least one embodiment, the time-based indicator comprises a markingthat fades or appears over time.

In at least one embodiment, the time-based indicator comprises aclocking mechanism that provides at least one of a visual or audibleindication at the end of a predetermined time period.

In at least one embodiment, the time-based indicator comprises anindicator provided with a plurality of LCD bars that darken uponpressing and holding a reset button and the bars lighten sequentiallyover predetermined time periods.

In at least one embodiment, the means for indicating an amount of wearcomprises a wear indicator configured such that at least one of a colorchange or marking appears or fades to indicate wear.

In at least one embodiment, the system further includes a computerprocessor, wherein the means for indicating an amount of wear comprisesthe computer processor configured to track cumulative time of use of atleast one of the skin contact member and the conduit.

In at least one embodiment, the means for indicating amount of wearcomprises a processor; wherein the processor is configured to: track aposition of the driving mechanism relative to the conduit; correlatepressure changes in the conduit relative to the position of the drivingmechanism when the conduit is first used; continue to correlate thepressure changes relative to the position during continued uses of theconduit; compare correlation values from the continued correlations withcorrelation values from the correlations when the conduit is first used;and indicate an amount of wear of the conduit based on the comparison ofcorrelation values.

In at least one embodiment, the processor is included in the breast pumpsystem.

In at least one embodiment, the processor is in an external computer,external to the breast pump system.

In at least one embodiment, the time-based indicator comprises aprocessor configured to track usage time of at least one of the skincontact member and the conduit.

In at least one embodiment, at least one of the skin contact member andthe conduit is provided with a passive sensor, and the processor isconfigured to track the passive sensor during use of the system.

According to another aspect of the present disclosure, a method ofoperating a system for pumping milk includes one or more of: providingthe system comprising a skin contact member configured to form a sealwith the breast, a conduit in fluid communication with and connected tothe skin contact member; a driving mechanism including a compressionmember configured to compress and allow decompression of the conduit inresponse to inward and outward movements of the compression member, asensor, a controller configured to control operation of the drivingmechanism and to receive signals from the sensor, and a milk collectioncontainer in fluid communication with the conduit; sealing the skincontact member to the breast; operating the driving mechanism to extractmilk from the breast and pumping the milk into the milk collectioncontainer; and calculating a volume of milk pumped into the milkcollection container, based on dimensions of the conduit and positionsof the compression member.

In at least one embodiment, the calculating a volume of milk pumpedcomprises: calculating a total volume pumped based on the dimensions ofthe conduit and the positions of the compression member; calculating thevolume of milk pumped as a percentage of the total volume, based on acompliance assessment of the conduit performed by comparing pressurechanges of the conduit to positions of the compression member.

In at least one embodiment, the system further includes a one-way valveinterconnecting the conduit and the milk collection container, and themethod further includes: monitoring the one-way valve to determine whenmilk begins to flow into the milk collection container and stops flowinginto the milk collection container; wherein the calculating a volume ofmilk pumped into the milk collection container, is based on dimensionsof the conduit and positions of the compression member over a timeperiod during which milk is flowing into the milk collection container.

According to another aspect of the present disclosure, a nipple shieldincludes one or more of: a central region configured to cover a nippleof a breast and having a first thickness; an attachment portionsurrounding the central region, the attachment region being configuredto attach to the breast and having a second thickness; wherein thesecond thickness is greater than the first thickness; and wherein thecentral region comprises one or more openings to allow milk to passtherethrough.

In at least one embodiment, the first thickness is a thickness in therange of about 0.2 mm to about 1 mm and the second thickness is athickness in the range of about 2 mm to about 5 mm.

In at least one embodiment, the first thickness is about 0.25 mm.

These and other features of the disclosure will become apparent to thosepersons skilled in the art upon reading the details of the systems andmethods as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a breast pump system (without milkcollection container) according to an embodiment of the presentdisclosure.

FIG. 2 shows a distal, perspective view of the system of FIG. 1 , withthe outer shell having been removed/made transparent to show componentsotherwise covered by the outer shell.

FIG. 3 shows a view as in FIG. 2 , but with the skin contact memberremoved to illustrate more details of the pumping region.

FIG. 4 illustrates components of a system according to an embodiment ofthe present disclosure.

FIG. 5 is a partial view of the system of FIGS. 2-3 showing acompression member and driver in more detail.

FIG. 6 is a partial view of the system of FIGS. 2-3 showing anothercompression member and driver in more detail.

FIG. 7A schematically illustrates one exemplary operation mode of thecompression members according to an embodiment of the presentdisclosure.

FIG. 7B schematically illustrates one exemplary operation mode of thecompression members according to an embodiment of the presentdisclosure.

FIG. 7C schematically illustrates one exemplary operation mode of thecompression members according to an embodiment of the presentdisclosure.

FIG. 8 illustrates a side view of a skin contact member according to anembodiment of the present disclosure.

FIG. 9 illustrates a side view of a prior art breast flange.

FIG. 10A is a sectional view of structure shown in FIG. 8 .

FIG. 10B is a sectional view of an alternative embodiment of a nipplereceiving portion according to an embodiment of the present disclosure.

FIG. 11A is a longitudinal sectional view of structure shown in FIG.11B.

FIG. 11B is a distal end view of a skin contact member according toanother embodiment of the present disclosure.

FIG. 12A is a side, cross-sectional view of a skin contact memberaccording to an embodiment of the present disclosure.

FIG. 12B is a transverse, cross-sectional view of the skin contactmember of FIG. 12A taken from the bottom of the system, showing the skincontact member and tube with the outer shell.

FIG. 12C is a proximal end view of the skin contact member of FIG. 12Ashowing a tube connected thereto.

FIG. 13 is a schematic representation showing components defining thetotal system volume according to an embodiment of the presentdisclosure.

FIG. 14 shows a compression member compressing a tubing portion,according to an embodiment of the present disclosure.

FIG. 15 is a chart illustrating relationships between tubing volume,tubing deflection and load on the compression member, according to anembodiment of the present disclosure.

FIG. 16 illustrates compression of a tubing portion by a compressionmember, according to an embodiment of the present disclosure.

FIG. 17 shows the power consumption data for a system according to anembodiment of the present disclosure.

FIG. 18 is an end view of an external shell of a system according to anembodiment of the present disclosure.

FIG. 19 shows characteristics of systems using various tubingdimensions, according to various embodiments of the present disclosure.

FIG. 20 is a schematic representation of working components of a systemaccording to an embodiment of the present disclosure.

FIG. 21A shows a proximal perspective view of a skin contact memberaccording to an embodiment of the present disclosure.

FIG. 21B shows a side view of a skin contact member according to anembodiment of the present disclosure.

FIG. 21C is a cross-sectional view of FIG. 21C taken along line 21C-21Cin FIG. 21A.

FIG. 21D shows a strain gauge mounted on or in a skin contact memberaccording to an embodiment of the present disclosure.

FIG. 21E shows a cross-sectional illustration of a nipple receivingportion in which a first non-contact sensor has been attached to arelatively thinner wall of the nipple receiving portion and a secondnon-contact sensor has been attached to a relatively thicker wall of thenipple receiving portion.

FIG. 21F shows a pressure sensor mounted on or in a skin contact memberaccording to an embodiment of the present disclosure.

FIG. 22 shows an indicator mounted on the inside of a breast contactmember so that it can be readily viewed by a user prior to mounting thesystem to the breast, according to an embodiment of the presentdisclosure.

FIG. 23 illustrates another location in which an indicator may beplaced, according to an embodiment of the present disclosure.

FIG. 24 illustrates an example of a reusable, time-based indicator thatmay be employed, according to an embodiment of the present disclosure.

FIG. 25 illustrates tracking of a skin contact member and/or tubing by acontroller of the system and/or an external computer, according to anembodiment of the present disclosure.

FIG. 26 shows a wear indictor located on a tubing portion, according toan embodiment of the present disclosure.

FIG. 27 illustrates a wear indicator on a skin contact member, accordingto an embodiment of the present disclosure.

FIG. 28 illustrates an example of an arrangement for tracking acompression member position, according to an embodiment of the presentdisclosure.

FIG. 29A illustrates one or more tacky regions provided to facilitaterestriction of the breast, according to an embodiment of the presentdisclosure.

FIG. 29B illustrates one or more tacky regions provided to facilitaterestriction of the breast, according to an embodiment of the presentdisclosure.

FIG. 30A illustrates a skin contact member having a relatively largerinternal angle.

FIG. 30B illustrates a skin contact member having a relatively smallerinternal angle.

FIG. 30C illustrates a portion of the areola at the juncture with thenipple that needs ample room to expand for optimal extraction of milk.

FIG. 31A schematically illustrates a breast pump system according toalternative embodiments of the present disclosure.

FIG. 31B schematically illustrates a breast pump system according toalternative embodiments of the present disclosure.

FIG. 32A illustrates a milk collection container for use in a systemaccording to another embodiment of the present disclosure.

FIG. 32B illustrates a milk collection container for use in a systemaccording to another embodiment of the present disclosure.

FIG. 32C illustrates a milk collection container that is formed so thatthe distal surface of the container, when filled with milk has a shapethat matches the proximal surface contour of the external shell of thesystem, according to an embodiment of the present disclosure.

FIG. 33 shows a milk container having baffles that internally connect tothe internal walls of portions of the container, according to anembodiment of the present disclosure.

FIG. 34 illustrates a milk collection container that includes a passivesensor, according to an embodiment of the present disclosure.

FIG. 35 illustrates a milk collection container wherein the connectorcontains a one-way valve, according to an embodiment of the presentdisclosure.

FIG. 36 illustrates a milk collection container according to anotherembodiment of the present disclosure.

FIG. 37 illustrates a milk container provided with an easilyidentifiable marking, according to an embodiment of the presentdisclosure.

FIG. 38 illustrates events that may be carried out to perform a purgeaccording to an embodiment of the present disclosure.

FIG. 39A illustrates various arrangements that may be provided to thesystem to help prevent loss of milk out of the system upon detachment ofthe system from the breast, according to embodiments of the presentdisclosure.

FIG. 39B illustrates various arrangements that may be provided to thesystem to help prevent loss of milk out of the system upon detachment ofthe system from the breast, according to embodiments of the presentdisclosure.

FIG. 40A illustrates a different cross-sectional view of a contourelement provided with a breast pump system according to an embodiment ofthe present disclosure.

FIG. 40B illustrates a different cross-sectional view of a contourelement provided with a breast pump system according to an embodiment ofthe present disclosure.

FIG. 41A illustrates a single thin layer of plastic or fabric used as acontour element, according to an embodiment of the present disclosure.

FIG. 41B illustrates a single thin layer of plastic or fabric used as acontour element, according to an embodiment of the present disclosure.

FIG. 42 illustrates a contour element fitted on an external shell inwhich the external shell is provided with a key that ensures that thecontour element is properly oriented on the external shell each time thetwo components are mated, according to an embodiment of the presentdisclosure.

FIG. 43 illustrates a contour element in which a first edge of thecontour element overlaps a second edge, and can be adjusted to reduce,increase or maintain the circumference of the distal perimeter, while atthe same time reducing, increasing or maintaining the proximalperimeter, according to an embodiment of the present disclosure.

FIG. 44 illustrates a contour element provided with predeterminedmarkings that may be provided to assist the user in adjusting thecontour element to better contour to the breast that it is to be usedon, according to an embodiment of the present disclosure.

FIG. 45A illustrates an external shell provided with two keys, accordingto an embodiment of the present disclosure.

FIG. 45B illustrates a contour element provided with mating keys thatare configured to mate with the keys of the external shell of FIG. 45A.

FIG. 46A illustrates a contour element according to another embodimentof the present disclosure.

FIG. 46B illustrates a contour element according to another embodimentof the present disclosure.

FIG. 47 illustrates events that may be carried out by a system during anextraction mode of pumping milk from a breast, according to anembodiment of the present disclosure.

FIG. 48 illustrates a nipple shield according to an embodiment of thepresent disclosure.

FIG. 49 schematically illustrates apparatus used to perform testing on alight body vinylpolysiloxane breast flange.

FIG. 50 illustrates results from the testing apparatus used in thetesting described with regard to FIG. 49 .

FIG. 51 schematically illustrates modified apparatus used to test thedynamic force-pressure relationship of a system, according to anembodiment of the present disclosure.

FIG. 52 illustrates results from the testing apparatus used in thetesting described with regard to FIG. 51 .

FIG. 53 illustrates results from the testing apparatus used in thetesting described with regard to FIG. 51 .

FIG. 54 schematically illustrates apparatus used to test therelationship between the position of a target location of a nipplereceiving portion and vacuum level within the nipple receiving portion,according to an embodiment of the present disclosure.

FIG. 55 schematically illustrates apparatus used to test therelationship between the position of a target location of a nipplereceiving portion and vacuum level within the nipple receiving portion,according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Before the present systems and methods are described, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the disclosure. The upper and lower limits of these smallerranges may independently be included or excluded in the range, and eachrange where either, neither or both limits are included in the smallerranges is also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present disclosure, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “asensor” includes a plurality of such sensors and reference to “the pump”includes reference to one or more pumps and equivalents thereof known tothose skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Thedates of publication provided may be different from the actualpublication dates which may need to be independently confirmed.

Definitions

The term “dead space” as used herein refers to volume within the systemthat is not directly acted upon by the pump of the system. Dead space iscalculated by the total volume minus the active pump volume. The totalvolume is the volume in the skin contact member 10 and tubing 32, fromthe nipple receiving portion 112 to the one-way valve 50, when thesystem 100 has been attached and sealed to a breast 2, such that thetotal volume is the space in the nipple receiving portion 112 notoccupied by the nipple 3/areola 4, and the remaining volume from thereto the one-way valve 50. The active pumping volume is the volumedisplaced by the compression member (e.g., compression member 38)whenthe compression member is moved from one limit of a full stroke to theother limit. The nipple will also move with a changing pressure; thetotal system volume change is the combination of these two (plus anyminor system compliance).The dead space is the non-pumping volume of thesystem.

“Let down mode”, as used herein, refers to a mode where the vacuumprofile is characterized by higher frequency and shallower (smaller)magnitude changes in vacuum level. Let down mode may also be referred toas “non-nutritive suction mode” or “non-nutritive mode”.

“Extraction mode”, as used herein, refers to a mode where the vacuumprofile is characterized by lower frequency and deeper magnitude changesin vacuum, relative to “let down mode” (non-nutritive mode). Extractionmode may also be referred to as “nutritive suction mode” or “nutritivemode”.

“Purging” refers to an act of transferring milk from the active pumpingregion of the pump tube into the collection chamber or bag.

“Latch suction” or “latch vacuum” refers to a minimum vacuum levelestablished when the pump is attached to the breast. This is set at thelowest level of vacuum, a pressure which is below atmospheric pressure,which is effective to attach the system to the breast.

Detailed Description

FIG. 1 is a side view of a breast pump system 100 (without milkcollection container) according to an embodiment of the presentdisclosure. The outer shell 34 of system 100 is shaped and configured tobe contoured to the breast of a user and to thus provide a more naturalappearance when under the clothing of the user. As can be appreciatedfrom the figures, the system can define a natural breast profile. Thenatural breast profile is contemplated to fit comfortably andconveniently into a bra of a user and to present a natural look. Assuch, the profile is characterized by having a non-circular base unlikethat embodied in a generally dome-shaped configuration. Extending fromthe base are curved surfaces having asymmetric patterns. Moreover, likenatural breasts, the profile of the device or system is contemplated todefine one or more asymmetric curves and off-center inertial centers.Various natural breast shapes can be provided to choose from to thetastes and needs of a user. FIG. 2 is a distal, perspective view of thesystem 100 of FIG. 1 , with the outer shell 34 having been removed/madetransparent to show components otherwise covered by the outer shell 34.System 100 includes a skin contact member 10 (such as the breast flangeshown in FIG. 2 , or member having a different shape, but configured toseal to the breast of a wearer and provide fluid communication with thepump) a pumping region 30 and a conduit 32. FIG. 3 shows a view as inFIG. 2 , but with the skin contact member 10 removed to illustrate moredetails of the pumping region 30.

FIG. 4 illustrates components of a system 100 according to an embodimentof the present disclosure. Conduit 32 includes a large conduit portion32L that is relatively larger in cross-sectional inside area than thecross-sectional inside area of small conduit portion 32S. Although bothportions 32S and 32L are shown as tubular portions being circular incross-section, the present disclosure is not limited to such, as one orboth portions could be shaped otherwise. For example, the conduit region32L in the embodiment of FIG. 3 is not cylindrical, but is formed as apump chamber having a substantially oval face 32F and walls that extendsubstantially perpendicular thereto. Further details of this embodimentof conduit region 32L can be found in U.S. Provisional Application Nos.62/052,476 filed Sep. 19, 2014 and 62/053,095 filed Sep. 10, 2014, bothof which are hereby incorporated herein, in their entireties, byreference thereto. The conduit region 32S2, which joins one way valve 50and large conduit region 32L in fluid communication, may be, but is notnecessarily of the same dimensions as small conduit region 32S. Likeregions 32S and 32L, region 32S2 may be cylindrical and circular incross section, but need not be. When tubular, the cross-sections may beoval square, other polyhedral shape, non-symmetrical, or non-geometricshape.

In the embodiment of FIGS. 2-3 , latching, pumping and extraction forcesare established by two compression members 36, 38 which are activelydriven by drivers 44 and 46 respectively. Although more than twocompression members could be used and one or more than two drivers couldbe used, the currently preferred embodiment uses two compression membersrespectively driven by two drivers as shown. FIG. 5 is a partial view ofthe system 100 of FIGS. 2-3 showing compression member 36 and driver 44in more detail. FIG. 6 is a partial view of the system 100 of FIGS. 2-3showing compression member 38 and driver 46 in more detail.

FIGS. 7A-7C schematically illustrate one exemplary operation mode of thecompression members 36, 38 according to an embodiment of the presentdisclosure. In FIG. 7A, tubing portions 32S and 32L are closed off, orsubstantially closed off by compression members 36 and 38, respectively.Upon powering up the system 100 the compression member 36 opens asillustrated in FIG. 7B and the compression member 38 begins to withdrawaway from anvil surface 2232 which gradually increases the suction levelwithin tubing 32. When a predetermined maximum suction level is achieved(as confirmed by pressure readings taken from a pressure sensor,described below), the compression member 38 ceases its travel in thecurrent direction, and either maintains that position for apredetermined period of time (or moves slightly in the same direction tocompensate for decreasing suction as milk enters the system) when theoperating mode of the system 100 has a predetermined time to maintainmaximum suction, or reverses direction and compresses the tube 32L untilthe latch suction level is achieved. If the maximum suction level hasnot yet been achieved by the time that the compression member is fullyretracted away from the anvil surface 2232 on the first stroke, then thecompression member 36 again compresses the tube 32S to seal off thecurrent vacuum level in the environment of the breast, and thecompression member 38 fully compresses the tube portion 32L to squeezemore air out of the system (out through one-way valve 50). Then thecompression member 36 reopens to fully open tube portion 32S andcompression member carries out another stroke, again moving away fromthe anvil surface 2232 to generate a greater suction level. This cyclingcontinues until the maximum suction level is achieved. It is noted thatit is possible in some cases to achieve the maximum suction level on thefirst stroke, whereas in other cases, multiple strokes may be required.

FIG. 7B shows the tubing portion 32S fully open as the compressionmember 36 is released and compression member 38 is moving away fromanvil surface 2232 to increase suction within the tubing 32. Uponachieving the maximum suction, the system may be designed and programmedso that the compression member 38 does not travel to its fullestpossible extent in either direction to achieve the maximum and latchsuction levels, so as to allow some reserve suction and pressureproducing capability. When the maximum suction level has been achieved,and the pumping profile is programmed to return to latch pressure, thecompression member 38 advances toward the anvil surface 2232,compressing tubing portion 32L, thereby raising the pressure in thetubing 32. Upon achievement of the latch suction pressure, compressionmember 36 closes off the tubing 32S again to ensure that the latchpressure is maintained against the breast, so that sufficient suction ismaintained. At this stage, the compression member 38 again begins movingaway from the anvil surface 2232 to increase the suction level back tomaximum suction, and compression member 36 opens (moves away from anvilsurface 2230) to allow tube 32S to open and the breast 2 to be exposedto the maximum suction. Alternatively, the system may be programmed sothat the compression member 38 cycles between maximum and latch suctionlevels without the compression member 36 closing during a point in eachcycle, with the compression member 36 closing when the latch pressure isexceeded.

Upon selection of a milk extraction mode, the compression member 36 andcompression member 38 function in the same manners as in the latch mode,but in a manner that follows an extraction waveform determined by theselected extraction mode. During the compression stroke of compressionmember 38, compression member 36 closes when the latch pressure/suctionlevel is achieved. Continued compression by the compression member 38(FIG. 7C) increases the pressure in the tubing 32 downstream of thecompression member 36 to establish a positive pressure to drive thecontents (milk) of tube portion 32L out of the tube portion 32L throughsmaller tubing portion 32S2 downstream of 32L and out through one-wayvalve 50. The positive pressure attained is sufficient to open theone-way valve for delivery of the milk out of the tubing 32 and into amilk collection container. In one embodiment, the positive pressure isin the range of 20 mm Hg to 40 mm Hg, typically about 25 mm Hg. Uponreversing the motion of compression member 38, compression member 36opens when the suction level returns to the latch suction level andcompression member 38 continues to open to increase the suction level tothe maximum suction level.

Prior art breast pump systems typically cycle between 0 mmHg (or closeto 0) and peak vacuum, which is typically up to 250 mmHg vacuum. Theflanges of the prior art systems (i.e., the component that contacts andseals to the breast) typically have a shaped, distal portion and a largecylinder section to accommodate the nipple of the breast as it is drawnforward into the cylinder by the application of vacuum. During pumpingwith these prior art pump systems, the nipple cycles back and forthsignificantly matching the cycling of vacuum from 0 to peak set vacuum.This motion is typically at least 1 cm of motion (nipple extends andcontracts by at least 1 cm) and can be significantly greater. Studieshave shown that the nipple motion resulting from a nursing baby is notvery large, e.g., on the order of about 4-5 mm of motion total (Eladpaper, other Hartman group papers).

The present disclosure establishes a latch vacuum to cause the skincontact member/breast flange 10 to seal to the breast. The latch vacuumestablished by the system is currently about 60 mmHg, but can be anyvalue in a range of from about 20 mmHg to about 80 mmHg. Once the system100 has been latched to the breast via skin contact member 10, thesystem then cycles between the latch vacuum and a target (also referredto as “peak” or “maximum”) suction level. Due to the fact that thesystem 100 does not cycle down to 0 mmHg, but maintains suction appliedto the breast, with the minimum end of the suction cycle being the latchsuction level (e.g., about 60 mm Hg), the nipple does not contract asmuch as it would with use of a prior art breast pump system. It has beenobserved that the nipple draws into the skin attachment member 10 withthe initial latch achievement in an analogous fashion as the formationof a teat during breastfeeding. Once the vacuum cycles between the latchand target vacuum levels, there is significantly less motion of thenipple back and forth with the vacuum changes, as compared to whatoccurs with use of prior art systems.. The nipple motion (distancebetween fully extended and fully retracted) during use of the presentsystem is typically less than about 2 mm, and in some cases less thanabout 1 mm.

This greatly reduced motion of the nipple during cycling results fromestablishment of the latch at latch vacuum level, and then limiting therange of vacuum swing between latch vacuum (suction) and peak vacuum(suction). Typically the difference in vacuum between latch vacuum andpeak vacuum is less than 200 mmHg, more typically less than 150 mmHg. Inone example, the latch vacuum was 50 mmHg and the peak vacuum was 200mmHg, resulting in a vacuum difference of 150 mmHg.

Limiting the nipple motion as described with use of the present systemoffers several benefits to the user. One benefit is that there is lessfriction on the side of the nipple against the flange wall, therebygreatly reducing the risk of irritation, skin damage, pain, swelling,etc. As a result, the present system is significantly more comfortableto use by a nursing mother, and this benefit is increasingly noticeableover repeated uses. By maintaining at least a latch suction level at alltimes, the present system provides a more secure and persistent seal tothe breast and significantly reduces the potential for leaks of airand/or milk. Because the nipple moves significantly less, this providesa more “natural” feel to the user that more closely simulates the feelof a nursing baby. Because the nipple travels less, this allows for theskin attachment member/flange 10 to be designed as a lower profilecomponent, as its length can be shorter since it does not need toaccommodate the greater length in nipple movement experienced by priorart systems. This allows the overall amount of protrusion of the system100 from the breast to less than that in the prior art, as the overalllength of the system is reduced by the reduction in length of the skincontact member/flange 10. Thus, the distance from the tip of nipple toexposed end of the housing the system is reduced.

FIG. 8 illustrates a side view of a skin contact member 10 according toan embodiment of the present disclosure. As shown, the breast contactportion 122 is symmetrical about the nipple receiving portion 112,although, alternatively, the nipple receiving portion 112 could beoffset in a manner as described herein. The overall length 110 of theskin contact member 10 in this embodiment is about 63.75 mm. FIG. 9illustrates a longitudinal sectional view of a prior art breast flange210. The overall length 212 of flange 210 is about 60.6 mm. The skincontact member 10 is designed to reduce the internal volume of thenipple receiving portion 112 relative to the internal volume of thenipple receiving portion 214 of the prior art device, which is enabledby the significantly reduced amount of motion experienced by the nipple3 during a milk extraction process using a system 100 including skincontact member 10, according to the present disclosure. The nipplereceiving portion 112 of the skin contact member 10 is contoured to moreclosely match the natural shape of the nipple, thereby eliminating orsignificantly reducing dead space that exists around the nipple in priorart systems. In the example shown, the nipple receiving portion 112 iscylindrical in the portion 112A adjoining the breast contact portion122, and then tapers conically in the portion 112B that extends fromportion 112A to the connector 134. This design allows for receiving aportion of the areola 4 into the nipple receiving portion 112A whilealso limiting dead space by providing the conical portion 112B. Thediameters of all cross-sections of the nipple receiving portion 112 arelarge enough to allow nipple dilation. The inside diameter of theconically tapering portion 112B tapers from an inside diameter equal tothe inside diameter of the cylindrical portion, down to a smaller insidediameter. As noted, the length of the nipple receiving portion 112 issignificantly less than that of the prior art. In the example shown inFIG. 8 , the length 114 of the nipple receiving portion 112 is about 23mm , as compared to the length 216 of 36.9 mm (may be in the range ofabout 350 mm to about 500 mm) of the prior art nipple receiving portion214.. Length 112 may vary within a range of about 22 mm to about 29 mm.The length 114 of the nipple receiving portion 112 is sufficient toallow engorgement of the nipple 3 under vacuum, without the distal tipof the nipple 3 contacting the proximal end of the nipple receivingportion 112.

Experimentation with the present system 100 has shown that the majorityof women’s nipples extend into the nipple receiving portion 112 with alength of about 1.6 cm under latch suction of about 50 mmHg (-50 mmHgpressure). The extra length provided by the nipple receiving portion 112(beyond the length of the nipple under latch vacuum is provided to allowfor a small amount of extension of the nipple under target vacuum,typically about 1-2 mm under maximum suction of about 150 mmHg, and toallow for a small amount of additional forward motion the nipple mayexperience as the pump primes. Accordingly, there is provided at leastabout 2 mm, up to about 6 mm of space in the nipple receiving portionthat extends lengthwise proximally of the tip of the nipple 3 when it isunder latch pressure.

The diameter 116 of the nipple entrance to the nipple receiving portion112 is large enough to accommodate the majority of nipple sizes so thatthe nipple is not constricted from some engorgement while under vacuum.The nipple 3 expands in diameter by a large amount at the base (theregion that joins the areola 4) than it does at the tip, which allowsthe nipple receiving portion 112B to be made conical-shaped, as shown.The diameter 116 of the entrance opening of the nipple receiving portion112, in the embodiment of FIG. 8 is about 24 mm, but may be in a rangeof about 22 mm to about 29 mm. The inside diameter 118 at the proximalend of the nipple receiving portion 112B is about 13.16 mm in FIG. 8 ,but can be in the range of about 9 mm to about 20 mm. In contrast, theinside diameter 218 of portion 214 of flange 210 is about 23.5 mm overthe entire length of the portion 214.

A portion of the areola 4 may also be drawn into the nipple receivingportion 112, so that it is alternately compressed and at least partiallyrelieved of compression by the pumping system 100 to simulate the way ababy naturally feeds. However, the skin contact member 10 is configuredto restrict the areola 4 from completely entering the nipple receivingportion 112 and to restrict portions of the breast 2 other than thenipple 3 and areola 4 from entering the nipple receiving portion 112.This prevents the tip of the nipple 3 from contacting the proximal endof the nipple receiving portion 112, even under maximum vacuum.

In any of the embodiments of skin contact member 10 disclosed herein,the top part of the nipple receiving portion 112 may be formed of arelatively harder and/or stiffer material and the bottom part of thenipple receiving portion 112 may be formed of a relatively softer and/ormore flexible material to better simulate a nursing baby during use, asthe baby’s tongue, which contacts the bottom of the nipple 3 is softerand more flexible than the baby’s palate, which contacts the top of thenipple 3 during nursing.

To facilitate restriction of the breast 2, the breast contact portion122 may be provided with one or more tacky regions 360, see FIGS.29A-29B. Although shown as continuous ring about the interior surface ofbreast contact portion 122 in FIGS. 29A-29B, tacky region 360 may spanone or more portions of this circumference and can be provided as one ora plurality of segments. The tacky region(s) provide more friction withthe breast 2 than does the remainder of the skin contact member 10,thereby providing resistance to the portions of the breast 2 thatcontact it, preventing it from being drawn in toward nipple receivingportion 112. The tacky region 160 may be formed by a different materialthan the remainder of the skin contact member 10, and/or may be acoating or roughened area to provide the increase in friction. Forexample, the tacky region may be silicone, with the remainder of theskin contact member being formed of polyethylene, or one of the othermaterials described herein for using in making the skin contact member.By preventing these portions of the breast from sliding into the nipplereceiving portion 112, this reduces incidences of pain from compressionof too much breast tissue, and provides sufficient space in the nipplereceiving portion 112 for the nipple 3 to naturally engorge for milkvolume expression.

The internal angle 120 of the breast contact portion 122 of the skincontact member 10 is designed for use with the present system 100 and tomaximize comfort of the user. The internal angle may also facilitate theability to restrict portions of the breast 2 from moving forward toomuch into the nipple receiving portion 112. In the embodiment of FIG. 8, the internal angle 120 is about 112°, which is wider than the internalangle of prior art flanges. For example, the angle 218 of the breastcontact portion 220 of the prior art flange 210 is ninety degrees. Thewider angle 120 helps to prevent the breast tissue from being funneledinto the nipple receiving portion 112, so that less breast tissue isreceived in the nipple receiving portion 112, making use of the presentskin contact member 10 more comfortable than flanges of the prior artand providing space for nipple engorgement. By providing the wider angle120, this also allows the overall system to be effectively shortened andallows the system to lie flatter against the breast to improve bothcomfort and appearance. In the embodiment of FIG. 8 , the length 124 ofthe breast contact portion 122 is 15 mm, but may be in the range of fromabout 12 mm to about 19 mm. In contrast, the length 222 of breastcontact portion 220 is 25.8 mm, which causes a system using flange 210to extend further out from the breast than would a system using the skincontact member 10.

FIGS. 30A-30B illustrate differences between skin contact members 122Ahaving a relatively larger internal angle 122A and skin contact member122B having a relatively smaller internal angle 122B. The smaller angle122B provides the ability to interact with relatively more breast tissueon more variations in breast sizes and shapes. The breast contactportion of 122A of the skin contact member shown in FIG. 30A has aninternal angle 120A that is larger than the internal angle 120B ofbreast contact member 122B shown in FIG. 30B. As a result, when theseskin contact members 10 are mounted to the breast 2, the initial contactof the breast tissue to the breast contact member 122A at 362A is loweron (or further into) the breast contact portion 122A than where thebreast tissue initially contacts breast contact member 122B at 362B. Thehigher (or further out) initial contact location 362B of the breast 2 onthe breast contact portion 122B provides more contact surface (comparelength 364B to 364A) of the breast 2 on the breast contact portion 122,which better controls the tissue movement in the nipple receivingportion 112 and creates more tension on the teat as it forms, due to theincrease surface contact area available. The teat starts to form soonerand the increased tension on the breast aids in holding back breasttissue 2 and the distal portion of the areola 4 from being sucked intothe nipple receiving portion 112. A larger length 366B and area for theareola 4 and nipple 3 to form a teat are provided by the smaller angle120B, relative to the length 366A and area of the embodiment in FIG.30A, as length 366B is greater than length 366A by an amount sufficientto make the internal volume of the skin contact member over the length366B greater than the internal volume of the skin contact member overthe length 366A. With the larger angle 122A of the embodiment in FIG.30A, the areola contacts the sides of the breast contact portion 122Aupon initial contact of the breast 2 with portion 122A, so that there isno room for the areola 4 to expand. For optimal results, there needs tobe a lengthening and widening of the areola 4 during milk extraction, asthis is what occurs when a baby suckles. The space provided between theareola 4 and the opening to the nipple receiving portion 112 uponinitial contact of the breast 2 to breast contact portion 122, allowsthe areola 4 to lengthen and expand (widen) as the nipple 3 is drawninto the nipple receiving portion 112. FIG. 30C illustrates the portion4P of the areola 4 at the juncture with nipple 3 that needs ample roomto expand for optimal extraction of milk, as this portion includes milkducts that will not expel milk as efficiently, or at all, if they arenot allowed to expand. The skin contact members 10 of the presentdisclosure are preferably configured to allow up to about 0.25 inches (about 0.5 cm) length of the areola 4 to be drawn into the nipplereceiving portion 112, and to prevent additional portions of the areolafrom entering the nipple receiving portion 112.

The thickness of the material forming the breast contact portion 122 andnipple receiving portion 112 in the embodiment of FIG. 8B is about 1.5mm, but the thickness may be in the range of from about 1 mm to about 4mm. Alternatively, the thicknesses of the breast contact portion 122 andthe nipple receiving portion 112 may be different from one another. Thebreast contact portion 122 and nipple receiving portion 112, as well asthe tubing connector 134 can be made of silicone or other compliant,biocompatible material, such as, but not limited to polyurethane and/orpolyether block amides (PEBAX) to provide a soft interface with thebreast and also provide a seal around the areola and nipple of thebreast The inner housing 126 of the breast contact portion 122 can berigid, semi-rigid or compliant. Likewise, the nipple receiving portion112 can be rigid, semi-rigid or compliant. Part of the breast contactportion 122 that adjoins and serves as an entrance to the nipplereceiving portion 112, is configured to be in contact with at least theperimeter portions of the areola 4 and can be made of a less lubriciousmaterial (relative to the lubricity of the nipple receiving portion 112)to provide more frictional resistance on at least the perimeter of theareola to help prevent it from being drawn into the nipple receivingportion 112, and to provide tension on the breast tissue away from thenipple 3 and areola 4, to control the amount of areola 4 that is allowedinto the nipple receiving portion 112. Since the present system 100significantly reduces movement of the nipple 3 during pumping, thesurface that provides more friction and tension reduces the risks ofchafing or blistering of tissue that would be experienced in a currentlyavailable nipple flange, as they experience considerably more nipple 3movement during pumping. The nipple receiving portion 112 and innerhousing 126 can be made of different materials and/or hardnesses and/orrigidity. For example, the inner housing 126 can be rigid and the nipplereceiving portion 112 can be compliant, or any other combination ofmaterials, hardnesses and rigidities could be provided. Preferably thebreast contact portion 122 and nipple receiving portion 112 arecompliant and made from silicone, although other materials andcombinations of materials could be used, including, but not limited toor polyethylene terephthalate (PET), polyurethanes, polyethylene, highdensity polyethylene (HDPE), low density polyethylene (LDPE),polyamides, polyethylene terephthalate (PET) and/or PEBAX. For theembodiments where there is compliance, the nipple receiving portion 112may be capable of iteratively opening and closing during extraction ofmilk from the breast using system 100, thereby simulating a feedingcycle similar to the sequence of the tongue against the nipple when ababy is suckling.

In the embodiment of FIG. 8 , the nipple receiving portion 112 includesportion 112A which is cylindrical and portion 112B, which iscone-shaped, with the internal angle 130 of cone-shaped portion 112Bbeing about 60 degrees. The internal angle of the cone may be in therange of from about 55 degrees to about 65 degrees.

Both the cylindrical portion 112A and the cone-shaped portion 112B arecircular in cross-section, as exemplified by the cross-sectionillustration of FIG. 10A, which is taken along line 10A-10A in FIG. 8 .Alternatively, one or both of portions 112A, 112B may be ovular orelliptical in cross-section, as illustrated by 112A′, 112B′ in FIG. 10B.This ovular or elliptical cross-section more closely resembles the shapeof a suckling baby’s mouth and will therefore provide a pressure/forcecontour to the nipple that is more similar to the suckling of the baby.

Further alternatively, the skin contact member 10 may have an adjustableopening 132 to the nipple receiving portion 112 and also the flangeangle 120 may be adjustable, so that both the breast contact portion 122and opening can be sized to optimize the fit against the areola andreception of the nipple. In at least one embodiment, inserts areprovided on the inside of the breast contact portion 122. Additionallyor alternatively, inserts can be provided on the back of the breastcontact portion 122 In any of these arrangements, inserts change theangle of breast contact portion 122 relative to the breast 2 as it ismounted on the breast. Still further, an insert can be provided to makethe opening smaller. Different combinations of flange angle 120 andopening 132 diameter may be required for different sizes and shapes ofbreasts. For example, a relatively smaller opening 132 and relativelysmaller angle 120 may be required for a breast that is relatively moreelastic than average, while a relatively larger angle 120 and relativelylarger opening 132 may be better for a breast that is more taut thanaverage. Further alternatively, a series of skin contact members 10 maybe provided to provide a range in angle 120 and opening 132 variations.The wall thickness 128 may also be varied to accommodate changes in theangle 120 of the breast contact portion 122.

Portion 134 is the tubing connector that is used to connect the skincontact member 10 in fluid communication with the tubing 32. Thediameter 136 of the opening 138 that provides the fluid communicationwith the tube 32 is about 25 mm in FIG. 8 , but may be in the range offrom about 20 mm to about 28 mm. The length 142 of portion 134 is about23.8 mm in FIG. 8 , but may be in the range of from about 20 mm to about28 mm.

FIG. 11A is a longitudinal sectional view taken along line 11A-11A inFIG. 11B and FIG. 11B is a distal end view of a skin contact member 10according to another embodiment of the present disclosure. In thisembodiment, the nipple receiving portion 112 is not centered withrespect to the breast contact portion 122, in contrast to the embodimentof FIG. 8 where the breast contact portion 122 is concentric with nipplereceiving portion 112. Instead, in this embodiment, the central axis 146of the nipple receiving portion 112 is positioned below the central axis148 of the breast contact portion 122, when the skin contact portion isplaced in the orientation in which it is used for attachment to thebreast, see FIG. 11B. In this embodiment, the opening 132 to the nipplereceiving portion 112 is slightly larger in diameter than that of theembodiment of FIG. 8 , (25 mm vs. 23 mm) to accommodate users withslightly larger nipples. The opening diameter 219 of the prior artflange 210 shown in FIG. 9 can be in the range of about 21 mm to about32 mm. Of course, the offset embodiments of the present disclosure couldalso use the smaller opening 132 size. Likewise, the embodiment of FIG.8 could be provided with the larger opening 132 size. In this offsetembodiment, the angle 120A of the breast contact portion 122 that isabove the nipple receiving portion 112, relative to the central axis 150of the breast contact portion 122 (and the central axis 164 of thenipple receiving portion 112 when the central axes 150 and 164 areparallel, as in the embodiment of FIG. 11A) is flatter than the angle120B of the breast contact portion 122 that is below the nipplereceiving portion 112, relative to the central axes 150 and 164, seeFIG. 11A. In other embodiments, central axis 150 is not parallel withcentral axis 164. In the example shown in FIG. 11A, angle 120A is about69 degrees and angle 120B is about 52 degrees. However, angle 120A maybe any angle in the range of from about 32 degrees to about 85 degreesand angle 120B may be any angle in the range of from about 32 degrees toabout 85 degrees. This configuration provides a better fit to thenatural curvature of the breast to which the breast contact portion 122is contacted, relative to a design where both angles 120A and 120B areequal. To maintain the plane of the perimeter around the distal opening152 of the breast contact portion 122 substantially normal to thecentral axis 150 as shown in FIG. 11A, the distance 154 from the top ofthe opening 132 to the top of the perimeter of distal opening 152 isgreater than the distance 156 from the bottom of the opening 132 to thebottom of the perimeter of distal opening 152, due to the difference inangles 120A and 120B. In the example shown in FIG. 11A, distance 154 isabout 36.32 mm, but may be any value in the range of from about 15 mm toabout 62 mm; and distance 156 is about 21.3 mm, but may be any value inthe range of from about 10 mm to about 58 mm. The outside diameter 158of the breast contact portion 122 at the distal opening (see FIG. 11B)is about 82.3 mm, but may be any value in the range of from about 60 mmto about 150 mm. The distance 160 from the top of the perimeter of thedistal opening 152 to the central axis 164 of the nipple receivingportion is about 49.8 mm in the embodiment of FIG. 11A, but may be anyvalue in the range of from about 30 mm to about 60 mm. The distance 162from the bottom of the perimeter of the distal opening 152 to thecentral axis 164 of the nipple receiving portion in the embodiment ofFIG. 11A is about 33 mm but may be any value in the range of from about25 mm to about 40 mm. In contrast, the flange 210 of FIG. 9 issymmetrical, with the distance 254 from the top of the perimeter of thedistal opening to the central axis of the flange 210 being 28.2 mm andthe distance 256 from the bottom of the perimeter of the distal openingto the central axis of the flange 210 being 28.2 mm.

Multiple holes or ports 140 are provided at the interface of the nipplereceiving portion 112 with the tubing connector 134 to allow the breastmilk drawn from the nipple 3 to enter the tubing 32 connected to thetubing connector 134 and in fluid communication with holes/ports 140.These holes/ports 140 allow milk to be delivered into the tubingconnector 134 and tubing 32, and also prevent the nipple 3 from beingdrawn into the tubing connector 134 and tubing 32.

FIG. 12A is a side, cross-sectional view of the skin contact member 10and tube 32 with the outer shell 34. FIG. 12B is a transverse,cross-sectional view from the bottom of the system 100 showing the skincontact member 10 and tube 32 with the outer shell 34. Although tube 32is shown schematically as a single sized tube for simplicity, the largeportion 32L in this embodiment has an inside diameter larger than theinside diameter of smaller tube portions 32S. FIG. 12C is a proximal endview of the skin contact member 10 showing tube 32 connected thereto. Inone embodiment, the inside diameter of the tube 32L is about ⅜″. Inanother embodiment, the inside diameter of the tube 32L is about 7/16″.In another embodiment, the inside diameter of the tube 32L is about ½″.In another embodiment, the inside diameter of tube portion 32L is about5/16″. In one embodiment, the inside diameter of tube portions 32S and32S2 is about 1/4″. In another embodiment, the inside diameter of tubeportions 32S and 32S2 is about 3/32″. In another embodiment, the insidediameter of tube portions 32S and 32S2 is about ⅛″.

In one embodiment, the total system volume is about 24.0 cc. The totalvolume is calculated as the space in the nipple receiving portion 112(that is not occupied by the nipple 3) and tube portions 32S, 32L and32S2 up to the one-way valve 50, see the schematic representation inFIG. 13 . Other embodiments may have a significantly less total systemvolume, in the range of about 4 cc to about 24 cc, preferably in therange of about 4.5 cc to about 12 cc, more preferably in the range ofabout 5 cc to about 8 cc or about 8 cc to about 10 cc. In the embodimentwith total system volume of about 24.0 cc, the active pump volume, i.e.,the volume displacement achievable by compressing tube portion 32L fromfully uncompressed to the limit of compression by compression member 38is about 3.4 cc. The compression member 38 in this embodiment has acompression member length 38L (with length defined as shown in FIG. 14 ,38L) of about 2.5”. When there is only air in the tubing 32 of thesystem 100, pressure swing by moving the compression member 38 inwardlyagainst the tubing portion 32L and outwardly away from the tubingportion is limited, due to the compressibility of the air. In thisembodiment, with the system under vacuum of -60 mmHg, a full stroke ofthe compression member (from compressed to fully uncompressed tubeportion 32L) increases the vacuum to -160 mmHg. The ratio of pumpingvolume to total system volume is important with regard to power and sizeof the pumping system. In this embodiment, the tube portion 32L was madeof silicone (Dow Corning SILASTIC®) having a 0.375’ inside diameter anda wall thickness of 0.094”, with a hardness of 50 Shore A. Using the2.5” long compression member, the force applied to the tube portion 32Lunder full compression was 19.6lbf.

In a preferred embodiment, it is preferred to avoid both completelycompressing the tube portion 32L and well as allowing full rebound ofthe tubing portion 32L. Near full compression, a sharp increase incompression force is required (see FIG. 15 , #302), which is notefficient for the small amount of additional pressure change obtainedthereby, given the significant increase in motor power and energyconsumption that it would require. Near full rebound of the tubingportion, the resulting pressure changes are less efficient, given theamount of energy expended by the driver 46 to withdraw the compressionmember 38 fully, see FIG. 15 , #305 During let down mode operation ofthe system 100, the system 100 operates to effect let down of the milkin the breast 2, prior to extraction, with a maximum suction target ofup to 120 mmHg (typically, about 100 mmHg (-100 mmHg pressure)) toestablish let down. The goal of letdown mode (or non-nutritive suctionmode) is to stimulate the breast 2 to express milk. The relativelyshallow (small vacuum change range) and relatively fast frequency of thepumping during this phase are meant to mimic the initial suckling actionof a child at the breast. In this mode, the first 10% of the tubingcompression (FIG. 15 , #305) is less productive. This is because duringlet down phase, the suction pressure is not allowed to exceed themaximum let down suction of 110 mmHg or 120 mmHg, or whatever themaximum let down suction is set at, so the compression member 38 doesnot cycle to the range of the first 10% of the tubing compression.Therefore, as the compression member 38 is drawn in a direction awayfrom the tube portion 32L, the system 100 is designed to reach -100 mmHg(a suction pressure of 100 mmHg) (or -120 mmHg, or whatever the maximumlet down suction is designed to be), by the time that the compressionmember 38 has reached a position in which tube 32L is 90% uncompressed,see 307. Further movement of the compression member 38 away from thetube portion 32L from 90% to 100% compressed (see region 305) is lesshelpful to generate additional vacuum as the tube portion 32L functionslike a weak spring during this portion of expansion. The chart in FIG.15 tracks the rebound pressure generation by the tube portion 32L aftercompression to a specific level. For example, 100% compression of tubeportion 32L followed by sealing the tube and letting it rebound wouldgenerate >300 mmHg. A small deflection generating 10 mmHg is not‘useful’ for pumping purposes of the system 100. 200 mmHg vacuum isestablished when the tubing 32L is about 25% compressed and thenreleased, see 309. The compression member 38 needs only to actuatewithin the ranges of vacuum generation that are useful for the pumpingpurposes of the system 100. Actuating the compression member 38 tocompress the tube portion 32L near 100% is inefficient due to thecompression load ramping up. Also, actuating the compression member 38paddle near 0% compression of the tubing portion 32L is only useful forcontrolling low vacuum peaks. As the tubing portion 32L rebounds itreaches its capacity for vacuum draw and further withdrawal of thecompression member 38 away from the tubing portion 32L only causes thepaddle to lose contact with the tubing portion 32L.

During let down (non-nutritive) mode the system 100 can be configured tooperate between -60 mmHg and -100 mmHg in one example. In this example,the compression member 38 can compress the tubing portion 32L nearlyfully (e.g., about 97%) and then be moved away from the tubing portion32L to generate vacuum. The maximum latch suction pressure of -100 mmHgwill be reached with a small amount of rebound of the tubing portion 32Land the compression member 38 can be cycled relative to the tubingportion 32L between -100 mmHg and -60 mmHg in a narrow range or bandnear full compression of the tube portion 32L. As milk flows, thatnarrow band shifts (volume in -> paddle lifting) until 100 is generatedaround 10% (90% rebound) at which point the tube portion 32L will bepurged by fully compressing it (up to or near 100% compressed) to driveout the contents and thereby regain more capacity for pumping withrelatively less compression of the tube portion 32L again. In anotherembodiment, compression member 38 operates in a range to compress tubeportion 32L from about 10% compressed up to about 97% compressed.Additionally, the compression member 38 can move to a position wheretube 32L is 0% compressed to allow for installation, changing, etc. ofthe tubing 32. Typically during purging, the vacuum level is reduced tominimum vacuum (e.g., about -60 mmHg) and the compression member 36 isused to close off (seal) tubing portion 32 to maintain 60 mmHg vacuumagainst the breast 2. Then the compression member 38 fully compressesthe tubing portion 32L to purge the contents of tubing portion 32L.

The contact surface of the compression member 38 can be shaped toimprove pumping efficiency and reduce power requirements of the system100. FIG. 16 shows an end view of compression member 38 duringcompression of tubing portion 32L. The contact surface 38S ofcompression member 38 is convex in the direction transverse to thelongitudinal axis of the compression member 38, such as by radiusing,for example, to avoid unproductive crushing of the side walls of thetube portion 32L. This minimizes the peak load on the driver 46. It canbe seen in FIG. 16 that the central portion of the tube 32L iscompletely closed as the inner walls contact one another, while theportions near the sides of the annulus do not completely close off.

For the embodiment having the total system volume of 24.0 cc, 19.6 lbs.pumping force was provided by the driver 46 and compression member 38.The estimated mechanism capacity was 44 lb. “Mechanism capacity” refersto the maximum compression force that could be applied to the tubingportion 32L by the driver 46 and compression member 38, and is a factorof voltage, driver 46 stall torque, and other characteristics of thedrive train, such as gear reduction, etc. The system used a servo motoras the driver 46 connected to the compression member 38 with a 0.188”lever arm 304 (see FIG. 14 ), to provide a 246:1 gear ratio and 5.9ft-lb. torque with a 500 mA current draw. The maximum desired speed ofthis pump system is 90 cycles/min (CPM), with full compression travellimited to about 65 CPM. When the compression travel (stroke) isreduced, such as when in letdown mode, the speed can be increased. Thepump system has a ‘dry’ 100 mmHg swing (i.e., change in vacuum is about100 mmHg from one end of a full stroke to the other when there is nofluid in the tubing 32), so the full travel stroke may not be requiredin letdown mode, as the vacuum swing is less than 100 mmHg, e.g., about60 mmHg latch suction to about 100 mmHg maximum suction. The forcerequirements of the pumping system can be greatly reduced by reducingthe dead space in the total system volume, which in turn then requiresless pumping volume per cycle/stroke. By reducing the gear ratio, thiscan increase the actuation of the compression member to make it quickerand more responsive to pressure changes.

The driver 44 and compression member 36 were configured to apply about1.0 lbf to the tube having ⅜″ inside diameter, to fully close (pinch) itoff. Driver 44 included an HS-85MG servo motor having dimensions of0.51” x 1.14” x 1.2”, a 3.0 in-lb. stall torque and 0.238” lever arm toprovide about 12.8 lbf capacity.

FIG. 17 shows the power consumption data for the system described abovehaving 24.0 cc total system volume, 0.375” inside diameter tube 32, and2.5” compression member 38 described above. The drivers 44, 46 werepowered by four alkaline “C” sized batteries which provided a voltage330 of about 6 V. The currents were measured using a multimeter inseries with the battery connection to the drivers. The system was set todrive the compression member 38 over the full stroke relative to thetube portion 32L during operation. A single 15 minute pumping sessionrequired about 110 mAh of power, see 336. An estimate for a day’s worthof pumping was set as four sessions, resulting in the power requirementfor a full day 338 to be about 440 mAh. The average current 332 wascalculated to be about 440 mA and the maximum current 334 capability wasabout 0.83 A.

In one embodiment, the external shell 34 that contains the othercomponents of the breast pump system (except for the milk collectioncontainer which is mountable over the external shell 34) is configuredto have about an 11 cm (4.3″) diameter 340 (see FIG. 18 ) and a length342 (see FIG. 1 ) of about 4.1 cm (1.6″), although the diameter 340 maybe any value within the range of from about 10 cm to about 14 cm and thelength 342 may be a value within the range of from about 3.5 cm to about6 cm. An external shell 34 having a diameter 340 of about 11 cm andlength 342 of about 4.1 cm provides a housing volume for the componentsof about 151.2 cc. Assuming dead volume in the nipple receiving portion112 to be about 1.8 cc and a 1 cm length of tubing 32 provided forcompression by compression member 36 with the nipple receiving portion112 off center of the breast contact portion 122 by about 1.5 cm, FIG.19 shows characteristics of systems 100 using various tubing dimensions.These characteristics were measured using tubing 32 that was uniformthroughout and thus did not have a smaller tubing portion 32S and largertubing portion 32L, but the principle still holds for using tubing 32having both small 32S and large 32L portions. It can be seen thatreducing the dead volumes 350 and 352, the pumping efficiency 354(pumping volume divided by total system volume 352 + 356) increases.This allows a reduction in the length 38L of compression member 38,resulting in relatively lower pump power and energy consumptionrequirements.

The system 100 is responsive to pressure changes within the tubing 32caused by entry of milk into the tubing 32. FIG. 20 is a schematicrepresentation of working components of the system 100 according to anembodiment of the present disclosure. The compression elements 36 and 38are driven by dedicated compression drivers 44, 46. Alternatively,compression elements 36 and 38 could be driven by a single compressiondriver, controlled by controller 52 to drive each of the compressionelements 36, 38 in the manner desired. As shown, the compressionelements 36, 38 comprise pistons, but alternative features could be usedto accomplish the same function, such as lever arms, screw drives,clamps, cams, pincers, rollers, magnets, electromagnets, linear drives,solenoids, gears, stepper motors, or other features, respectively.Further characteristics of alternative embodiments of compressionmembers and compression surfaces thereof can be found in U.S.Provisional Application Serial Nos. 62/027,685, filed Jul. 22, 2014;62/050,810, filed Sep. 16, 2014; 62/052,476, filed Sep. 19, 2014; and62/053,095, filed Sep. 19, 2014; each of which is incorporated herein,in its entirety, by reference thereto.

Each compression element 36, 38 is operatively connected to a driver 44,46, respectively, for independent, but coordinated driving andretraction of the compression elements 36, 38. When electrically-powereddrivers are used, a battery 48 is electrically connected to the drivers44, 46, as well as the controller 52 and pressure sensor 54, andsupplies the power necessary to operate the drivers 44, 46 to drive thecompression and retraction of the compression elements 36, 38.

A sensor 54 is used to provide feedback to the controller 52 forcontrolling the pumping cycles to achieve and/or maintain desired vacuumlevels. Sensor 54 is preferred to be a pressure sensor but could also bea flow, temperature, proximity, motion sensor or other sensor capable ofproviding information usable to monitor the safety or function of thepump mechanism of system 100. As shown, sensor 54 is a non-contactsensor 54, meaning that it is not in fluid communication with the milkor vacuum space of the system 100. Preferably sensor 54 is locatednearby where the tip of the nipple 3 of the breast 2 is located todetermine actual pressure being exposed to the breast 2/nipple 3, butother sensors 54 may be located within the system 100, for example, nearwhere the one-way valve 50 is located, and can be used to monitor otherfeatures such as container 60 contents or expulsion pressure or flowrate. More generally, sensor 54 can be located anywhere in the systembetween the breast 2 and the one-way valve 50 into the collectioncontainer 60. Sensor 54 can be located either on the breast side of thecompression member 36 or the other side of the compression member 36.When located on the breast side (i.e., upstream of the compressionmember 36), the sensor always provides the pressure experienced by thebreast 2 and can thus be used to monitor and determine the pressureenvironment of the breast 2 even when the compression member 36 hassealed off the tubing portion 32S. If the sensor 54 is on the other sideof the compression member 36 (i.e., downstream of the compression member36), sensor 54 can always provide pressure at the breast 2 except whenthe compression member 36 has sealed off the tubing portion 32S. Thus, asensor 54 can be placed anywhere in communication with tube 32 and beused to monitor and control the system via sensor readings feedback tothe controller 52. With at least one sensor 54 present, by monitoringeither flow or pressure directly or indirectly and also taking intoaccount the cycles and actual positions of the compression elements 36,38 over time, it is possible to derive/calculate approximately thevolume of milk produced during a pumping session as well as understandthe flow-rate at any particular time in a pumping session. The accuracyof this measurement is greatest when there is no leak of air around thebreast 2 and also when there is negligible air within the tube 32, afterelimination by a few cycles of the pumping mechanism.

A one-way valve 50 such as a duckbill valve or other type of one-wayvalve is provided at the end of tube 32 where it enters the milkcollection/storage container 60 (or, alternatively, can be connected influid communication with the storage container by another tube. Valve 50prevents back flow of milk into the tube 32, as well as preventing airfrom entering the proximal end of the tube 32 and thereby maintains thesuction (vacuum) level in the tube 32. Valve 50 can further be designedto open in the reverse direction, for safety purposes, if apredetermined maximum vacuum level is exceed in tubing 32, such asgreater than 250 mm Hg vacuum (-250 mm Hg pressure), for example. In atleast one embodiment, the pressure at which the valve 50 opens to allowflow into the milk collection container 60 is about 25 mm Hg. In analternative embodiment, a pressure relief valve 150 can optionally beprovided in the system 100, such as in the skin contact member 10, orother location along tubing 32. The pressure relief valve 150 can beconfigured to release at vacuums greater than a predetermined amount,(e.g., vacuums greater than 250 mm Hg (pressures less than -250 mm Hg),or some other predetermined maximum vacuum level). The one-way valve 50can be configured and designed such that it allows fluid to flow throughit when the pressure in tubing 32 is positive, e.g., about 25 mm Hg, orsome other predesigned “crack pressure”. The action of the compressionelements cycles between increasing vacuum when the compression elementsmove in a direction away from tube 32 and decreasing when thecompression elements compress the tube 32, but typically should notincrease the vacuum to greater than the predetermined maximum vacuum. Asthe compression elements 36, 38 compress the tube 32, the pressure inthe system 100 goes up and reaches the minimum suction level (e.g.,latch suction level, such as -60 mmHg, -30 mm Hg, or some otherpredetermined latch suction level), at which time the compression member(pinch valve) 36 seals off portion 32S thereby maintaining the minimumsuction (latch suction) against the breast 2. Continued compression ofportion 32L by compression member 38 continues to increase the pressuredownstream of compression member 36, until the crack pressure is reached(e.g., 25 mm Hg or some other predetermined, positive crack pressure),that opens the one-way valve 50. The compression elements 36, 38continue compressing tube 32, pumping fluid (milk) through the one-wayvalve 50 and into the collection container 60 until the compressionelement 38 reaches an end point in travel (typically before “bottomingout” against the anvil 2232). The end point in travel of the compressionelement 38 against portion 32L may be predetermined, or may becalculated on the fly by the controller 52 using feedback from pressuresensor 54 and feedback from the driver of the compression element 38,from which the controller 52 can calculate the relative position of thecompression element 38 over the course of its travel. The compressionmember 36 remains closed throughout this process, as it is used to sealoff the tube 32 the entire time that the compression element 38 ispumping milk out of the region 42 and into the collection container 60).As the compression elements 36, 38 reverse direction and pull away fromthe tube 32, they start the cycle again.

As milk enters the system, the suction level decreases (pressureincreases). The feedback provided by pressure monitoring via pressuresensor 54 provides input to a feedback loop that adjusts the position ofthe compression member 38 to maintain the desired vacuum (pressure)within the tubing 32 by compensating for the changes in pressure thatoccur to changing amounts of milk in the tubing 32. For example, for arelatively larger amount of milk in the tubing, this will require arelatively shorter stroke of the compression member 38 toward anvilsurface 2232 to achieve the latch pressure. This modification can beaddressed by either slowing the movements of the compression member 38to achieve the same timing cycle for pumping, or increasing the cyclefrequency due to the less time taken for the shorter strokes of thecompression member 38.

A contact pressure sensor 54 is shown in FIG. 4 , wherein the pressuresensor 54 contacts the vacuum space (and, potentially, the milk) in thesystem 100. In this embodiment, a T-connector 370 is connected to theproximal end of the nipple receiving portion 112, so that both tube 32Sand a tube 32P can be joined in fluid communication with the interior ofthe nipple receiving portion 112. In this way, pressure sensor 54 isplaced in line, in fluid communication with the tube 32 and nipplereceiving portion 112, and can measure pressure directly, as a result.

Alternatively, or additionally, one or more non-contact pressure sensorscan be employed in the system 100. In the embodiment of FIG. 20 ,non-contact pressure sensor is located external of the tubing portion32S. Various different types of non-contact pressure sensors can beused, such as optical sensors, magnetic sensors, linear variabledifferential transformer (LVDT) sensors, or the like. Further detailsabout non-contact pressure sensors that may be employed in the presentdisclosure can be found in U.S. Provisional Application Serial Nos.62/053,095 and 62/027,685.

FIGS. 21A-21B show a proximal perspective view and a side view,respectively, of skin contact member 10 according to an embodiment ofthe present disclosure, with four different potential locations forplacement of a non-contact sensor 54. At location 350A, a thicker wallis provided relative to the thickness of the nipple receiving portion112. In this example, the thickness of location 350A was 4.12 mm and thethickness of the nipple receiving portion 112 was 2.38 mm. At location350B, a thinner wall is provided relative to the thickness of the nipplereceiving portion 112. In this example, the thickness of location 350Bwas 1 mm and the thickness of the nipple receiving portion 112 was 2.38mm. At location 350C, the thickness was the same as the rest of thenipple receiving portion, but protruding outwardly therefrom, see thecross-sectional view of FIG. 21C taken along line 21C-21C in FIG. 21A.The thickness at location 350D is the same as the thickness of thenipple receiving portion; in this example, 2.38 mm. It has been foundthat all locations 350A-350D will displace relative to vacuum changeswithin the system according to a linear relationship (although bydifferent scaling factors, which can be determined empirically), seeExample 1 below. Accordingly, a non-contact sensor 54 can be employed atany of locations 350A-350D to measure displacement changes in thoselocations. Pressure change measurements can then be calculated from thedisplacement change measurements, due to the linear relationship thatexists between force applied to the locations 350A-350D and pressurewithin the system that causes the force. More generally, pressurechanges in the system 100 can be measured by measuring opposition forcesof any pre-loaded fluid contacting wall of the system 100.

Force versus displacement of a portion of the skin contact member 10,such as a portion of the nipple receiving member 112 also exhibits alinear relationship. Thus, displacement of a portion of the skin contactmember 10 can be measured and pressure change can be calculatedtherefrom. Further, strain measurement can be used to calculate pressurechanges. Therefore, attachment of a strain gauge 54 (see FIG. 21D) toskin contact member 10, typically on a region of nipple receiving member112, can be used to measure strain changes in that region, whichmeasurements can be used to calculate pressure changes within the nipplereceiving member 112.

Use of a system 100 provided with a non-contact pressure sensor 54 wouldinclude loading the skin contact member 10 onto the main body/pumphousing 34 (unless it has already been pre-loaded) and then turning onthe pump power. As the pump system 100 goes through a power up routine,the controller 52 reads the force applied by the pressure sensor 54,position of the sensor 54 relative to the potentiometer when adisplacement sensor 54 is used, or strain on the strain gauge when astrain gauge is used as the pressure sensor 54. This is the preloadforce applied by the sensor 54 to the wall of the nipple receivingportion 112 or tube 32, or position, or strain measured by the straingauge, before the skin contact member 10 has been applied to the breast2, so it is a state in which the pressure in tube 32 is atmosphericpressure. The controller 52 then calibrates the system such that thepreload force or position or measured strain equates to atmosphericpressure. Based upon a look-up table or a best fit equation, thecontroller 52 can now convert any changes in force, position or strainread by the pressure sensor 54 against the wall of the nipple receivingportion 112 or tube 32 to pressure readings in the system 100 duringoperation of the breast pump system 100 upon attachment to the breast 2.

Optionally, the system 100 may be provided with two or more non-contactsensors 54 for determining pressure within the system 100. For example,by placing sensors 54 on different regions of the nipple receivingportion 112 that have different wall thicknesses, the linearity of thepressure changes measured by the sensors 54 on the different wallthicknesses will occur within different ranges of pressure (vacuum).FIG. 21E shows a cross-sectional illustration of nipple receivingportion 112 in which a first non-contact sensor 54 (see 54A) has beenattached to a relatively thinner wall of the nipple receiving portion112 and a second non-contact sensor 54 (see 54B) has been attached to arelatively thicker wall of the nipple receiving portion 112. The sensor54B provides data for pressure change calculations at a higher range ofvacuum pressures (lower pressures) than that provided by the sensor 54A.The vacuum ranges in which the sensors 54A, 54B provide accurate data(linear relationship) can be designed to overlap, so that the effectiverange of linearity and thus the range for accurately measuring changesin vacuum pressure can be extended. Furthermore, when the vacuumpressure measured is in the overlap region, where reliable data isprovided by both sensors 54A and 54B, this can be used as a check on theaccuracy of each of the sensors 54A, 54B, and/or used for calibrationpurposes. The present disclosure is not limited to the use of one or twosensors 54, as more than two sensors 54 may be applied in this manner,with or without overlapping pressure measurement ranges, preferably withoverlap. FIG. 21F illustrates a pressure sensor 55 that may be employedto trigger or indicate when a predetermined vacuum pressure has beenattained within the system. Pressure sensor 55 may be a switch that isin electrical communication with the controller 52. Pressure sensor 55extends into the nipple receiving portion 112 (or, alternatively, tubing32) at a predetermined distance from an inner wall of the nipplereceiving portion 112/tubing 32 that has been calculated or empiricallydetermined to be the distance that the inner wall deflects when thepredetermined vacuum pressure has been attained in the nipple receivingportion 112/tubing 32. Accordingly, when the inner wall contacts thesensor 55 (as indicated by the dashed line in FIG. 21F), sensor 55 sendsa signal to the controller 52 and the controller interprets the signalto indicate that the predetermined vacuum level has been reached. Thistype of sensor 55 could be used, for example, to indicate when maximumvacuum has been achieved. Alternatively, or additionally, sensor 55could be provided to act as a safety mechanism, wherein the controller52 would shut down the system if a signal is received from the sensor55, as this would indicate that an abnormally high level of vacuum hasbeen reached. For example, the system may be shut down if 350 mmHgvacuum is reached, or some other predetermined level of vacuum that isconsidered to be too much vacuum for safe operation.

To account for the possibility of degradation of pump tubing 32 and/orthe skin contact member 10 over time the system can optionally beprovided with an indicator that will alert the user when it is time toreplace the skin contact member 10 and/or tubing 32. FIG. 22 shows anindicator 352 mounted on the inside of breast contact member 352 so thatit can be readily viewed by a user prior to mounting the system 100 tothe breast 2. Indicator 352 can measure a predetermined time/lifespan tochange tube 32 and/or skin contact member 10 via a time based indicator,such as markings that fade or appear over time, other clocking mechanismthat provides a visual and/or audible indication at the end of themeasured time. In the event that the skin contact member 10 and/ortubing degrades over time, such as resulting from fatigue and/oroxidation, washing, etc., indicator 352 can track an average expectedlifetime of the skin contact member 10 and/or tubing 32, and present avisible and/or audible indication to the user when it is time to replacethe current skin contact member 10 and/or tubing with a new component.Average expected lifetimes of these components can be determinedexperimentally through testing, so that the average expected lifetimecan be empirically calculated and programmed into the indicator. Changesin properties (e.g., elasticity, stiffness, etc.) of the tubing 32and/or skin contact member 10 could result in inaccurate pressurereadings, insufficient sealing of the skin contact member 10 to thebreast 10 causing air and/or milk leakage, reduced pumping performanceetc. Indicator 352 may be a time-based indicator, such as markings thatfade or appear over time.

FIG. 23 illustrates another location in which indicator may be placed,in this case on the external shell 34 of the system 100. If thesituation is that the time to replacement of the skin contact member 10is different from the time to replacement of the tubing 32, and in whichthe embodiment has a skin contact member 10 that is configured to beseparable from the tubing (some embodiments provide the skin contactmember 10 and tubing 32 as an integral unit), then two indicators 352may be provided, one set for a time to replacement of the skin contactmember 10 and the other set to the time to replacement of the tubing.

Indicator 352 may be disposable, such as the type used on the skincontact member 10 as shown in FIG. 22 or on tubing 32, or may bereusable, where appropriate, such as those mounted on the external shell34 as shown in FIG. 23 (although indicators 352 on shell 34 could alsobe made disposable and be removable from and replaceable on shell 34).FIG. 24 illustrates one example of a reusable, time-based indicator 352that may be employed. In this embodiment, indicator 352 is provided witha plurality of LCD bars 354 that darken upon pressing and holding thereset button 356. Once the bars have darkened, a timer that isinitiated, the timer having been programmed for the time to replacementof the skin contact member 10 and/or tubing 32. As shown in FIG. 24 ,the indicator has four bars 354, although more or fewer could beprovided. For the four-bar embodiment, when one-quarter of the time toreplacement has elapsed after the resetting of the bars, the top barbecomes clear, or lightens, so that only three bars remain visibly dark.Each bar sequentially lightens or clarifies after each successivepassing of a quarter of the time to replacement, until all bars areclear when the time period expires. Thus, this type of indicator notonly indicates when the full time to replacement has elapsed, but canalso provide the user with an indication of approximately how much timeis remaining until replacement is required, i.e., three dark barsindicates that ¾ of the use time still remains prior to the need toreplace, etc.

Alternatively, or additionally, other types of indicators 352 may beprovided, including, but not limited to: indicators that change withfriction, interaction with moving parts, or the like. For example, awear indicator 352 can be located anywhere on tubing 32, such as in alocation where compression member 38 contacts tube 32L, wherecompression member 36 contacts tube 32S, or in another location such aswhere tubing 32 snaps into the pump housing/region 30. FIG. 26 shows awear indictor located on tubing portion 32L. Wear indicator 352 may beplaced anywhere on tubing 32 where wear is likely to occur. Wear, suchas through friction resulting from interaction between tubing 32 andanother component (compression member 36 or 38, pump housing 30, etc.)wears away a color of the indicator 352 as the wear occurs. Thus, whenthe color disappears or changes color, this indicates that it is time tochange the tubing 32.

Likewise, a wear indicator 352 may be used on a component of skincontact member 10 in a location where it contacts the pump housing 30when it is snapped into position. FIG. 27 illustrates a wear indicator352 on skin contact member 10. Wear occurs as the skin contact member isattached to, and removed from the pump housing. Color change may be usedto indicate when it is time to change the skin contact member, in a waythat is described above.

Further alternatively, or additionally, the system 100 may detect tubing32 wear. Controller 52 can track the position of the compression member38 relative to tubing 32. FIG. 28 illustrates one example of anarrangement for tracking compression member 38 position, although thepresent disclosure is not limited to this arrangement, as alternativearrangements may be provided. In the embodiment of FIG. 28 , driver 46includes a motor 46M, a gear box 46G and an encoder 46E mounted toopposite ends of motor 46M. As motor 46M rotates, encoder 46E, which isfixed relative to the rotating motor shaft, rotates with the motor. Anoptical monitor 1146, such as an infrared laser or the like is beamedagainst the encoder 46E, such as the rotating blades of the encoder 46Ecross the optical beam emitted by the optical monitor 1146 as the motorrotates. As the blades cross the beam, the beam is reflected back to asensor 1148. By counting the reflections, the sensor 1148 and controller52 can calculate the position of the motor 46M from a start position,and thus the position of the compression member 38 that it is driving,relative to a reference or starting position of the compression member38. A similar arrangement can be provided for the driver 44 ofcompression member 36.

Thus controller 52 can keep track of the position of motor 46 and theposition of compression member 38 relative to the tubing 32L. Since thecontroller 52 also tracks the pressure within tubing 32 via sensor 54(e.g., as illustrated in FIG. 20 ), the controller 52 can correlatepressure changes developed in tubing 32 relative to position (and/oroptionally, speed) of compression member 38. This correlation can becalculated when tubing 32 is new, i.e., upon initial use. Correlationcalculations can be continually performed by controller 52 oversubsequent uses of the system, and compared to the correlation valuesfrom the first use. The correlation comparisons will show a trend overthe lifetime of the tubing 32 with subsequent uses. As the tubing 32begins to wear out, less pressure change may be produced by the samechange in position/speed of compression member 38 compared to when thetubing was new. This difference in pressure change can be tracked, and,when a predetermined amount of difference occurs, the controller 52 cansend a warning to display 165 and/or external computer 470, that it istime to change the tubing 32. Also, by tracking the trend in usage ofthe system 100 over time and the rate of change of difference inpressure change resulting therefrom, the controller can estimate andpredict when the time to change the tubing 32 will occur, and thus cansend a warning to display 165 and/or external computer 470 at apredetermined time before the tubing 32 will need to be changed. Forexample, such a warning could be sent one week, one month, or some otherpredetermined time before it is actually time to change the tubing 32.

Further alternatively or additionally, usage of the skin contact member10 and/or tubing 32 can be tracked by controller 52 and/or externalcomputer 470 using a passive sensor 358 (see FIG. 25 ) via RFID or NFC,for example. One or more sensors 358, each provided with a uniqueidentifier (ID) can be attached to or embedded into skin contact member10 and or tubing 32. With each use of the system, this/these uniqueID(‘s) can be identified by the controller 52 and/or external computer470 to know that the skin contact member 10 and/or tubing 32 has beenused, and the number of uses can thus be tracked, and/or times or useand/or cycle counts (number of cycles during use that the compressionmembers 38 and/or 3 have executed). By tracking this data, thecontroller 52 and/or external computer can then indicate when it is timeto change/replace the skin contact member 10 and/or tubing.

Further alternatively or additionally, the usage of the skin contactmember 10 and/or tubing 32 can be tracked, such as by usingradio-frequency identification (RFID) or near field communication (NFC)tracking. This tracking can be carried out, for example, by embedding apassive sensor/chip 358 configured to RFID or NFC tracking into one orboth of the skin contact member 10 and tubing 32, see FIG. 25 . The oneor more chips 358 can be identified by the controller 52 of the pumpingsystem 100 (by hard wire and/or wirelessly, preferably wirelessly) by anexternal computer 470, which may be, but is not limited to: asmartphone, a tablet computer, a laptop computer, a notebook computer ora server. The controller 52 and/or external computer 470 communicateswith the passive sensor(s)/chip(s) 358 which indicate(s) when the systemis in use. By tracking the times of use and/or number of uses, or evenpump cycle counts, the controller 52, or external computer can alert theuser when it is time to change the skin contact member 10 and/or tube32. Alerts may be audible and or visual, such as a beep or voice messageemitted from the external computer 470 via speaker 472 and/or a visualalert such as text and/or graphics displayed on display 478, or by thecontroller 52, via optional display 165 and/or optional speaker 168. Thetracking provided by the passive sensors 358 provide the ability toassign a unique identifier to each component that a sensor 358 isattached to or embedded in. Thus, the controller 52 and/or externalcomputer 470 can readily distinguish between each skin contact member 10and tube 32 used.

This same technology can be provided with the milk collection containers60, so that tracking of extraction date and time, volume extracted, etc.can be recorded and stored with regard to each milk collection containerused with the system 100 to extract milk. Thus, the system 100 canregister individual milk collection containers 60, so that the user canreadily identify when milk in each container 60 was collected, thevolume in each container 60, etc. The breast pump system can record thevolume of milk in any given container 60 during a pumping session. Thedata recorded can be sent to an external computer 470 and/or over theInternet, either automatically or manually.

There are multiple ways to link data to a particular milk collectioncontainer 60. Containers 60 may be provided with easily identifiablemarking 60M (see FIG. 37 ), such as alphanumeric markings (letters,numbers) of other markings that are readily identifiable anddistinguishable from one another. Additionally or alternatively, marking60M on each container 60 can include a barcode, QR code, RFID, NFC,other magnetic or electromagnetic identifier, or the like pre-printed onthe container 60. When initiating a milk pumping session using system100 with milk collection container 60 mounted thereto, or at the end ofthe session or anytime in between, the user can scan the mark with ascanner on an external computer 470 (smartphone or the like), or scanusing the system 100 itself in embodiments where controller 52 isprovided with a scanner 101 on the system 100 as illustrated in FIG. 1 ,or manually input the identifier of the mark 60M if no barcode is used,and thus link the particular milk collection container with the mark 60Min the database on the external computer. At the end of the milkextraction system, when data is exported to the external computer 470and/or Internet/cloud-based database, the data, such as volume,extraction date and time, etc. are exported along with the identifier ofthe mark 60M so the data is linked and stored relative to the identifierfor that particular milk collection container 60.

The mark 60M when in range of the controller 52 and/or external computer470 may automatically activate the system 100 for a pumping session, oractivate an activatable feature of the system, such as a power switchthat can be operated by the user to initiate a pumping session. If acontainer 60 contains a mark 60M that is not recognizable by thecontroller 52 and or external computer 470, or contains no mark 60M atall, then the system 100 may be configured so as to be prevented fromoperating for a milk extraction session, as no unique ID has beenrecognized in this instance. By ensuring that a milk collectioncontainer 60 used has a recognizable, unique ID, this can providedadditional assurances for safety, sterility and quality of the milkcollection container 60 used. The presence of the unique identifier 60Mallows the system 100 to track when the milk collection container 60enters into proximity with the system 100 for use in an extractionsession, when it leaves the proximity at the end of the session, as wellas other data already described, such as volume of milk extracted, dateand time of extraction, length of extraction session, etc. Theseinformation capabilities can be useful for managing personal use andconsumption by the user’s baby, as well as for milk donation services,where milk extracted from one mother may be donated to a milk bank, orto a baby having a different mother. With regard to milk donationservices, a collection bank can scan the milk collection container 60into the bank database using the same unique identifier provided by themark 60M and confirm that this is a container 60 that is qualified forthe program. In embodiments where container 60 includes the one-wayvalve 50, this provides further assurance that no milk has been removedfrom the container 60 prior to it arriving at the milk collection bank.

The controller 52 and/or external computer 470 may be provided withmemory storing a database of registered unique ID’s which can beregularly updated by communication with a central database through anetwork (either wirelessly or by wire) such as the Internet.Alternatively, controller 52 and/or external computer may connect withthe central database, such as by WiFi or other wireless connection tothe Internet, or even by Ethernet connection.

As already noted milk collection container 60 may be provided with apassive sensor 358, such as an RFID or NFC chip (see also FIG. 34 ),which may either be attached thereto or embedded therein, which can beused to link the milk collection container 60 to all data recorded inregard to it..

As an alternative to pre-marked collection containers 60, a user couldmanually mark the containers 60 with unique identifiers and manuallyenter these identifiers into the external computer. Alternatively, themanual marks could be scanned into the external computer.

The system 100 can calculate the volume of milk pumped into milkcollection container 60. By knowing the dimensions of the tubing 32downstream of the compression member 36 when compression member 36 hassealed off tubing portion 32S, the overall volume capacity of the system100 downstream of compression member 36 can be calculated. Tracking ofthe position of the compression member 38 relative to the tube 32 (suchas by knowing the driver 46 position at all times, for example),dictates the volume change in the tubing 32. As the pumping process iscarried out, pumping/purging of milk into the milk collection containeroccurs when the compression member 36 has closed off the small tubeportion 32S at the location of compression. When the compression member36 has closed off tube portion 32S, the change in position ofcompression member 38 that occurs to carry out the purge of milk fromthe tubing 32 and into the milk collection container 60 can be used tocalculate the change in volume of the tubing 32 downstream of thecompression member 36, which equates with volume of milk that is pushedinto the milk collection container 60 bag through the one way valve 50.

Optionally, an estimation of the percentage of milk and air in thesystem tubing 32 can be calculated based on a compliance assessment ofthe tubing 32, such as at tubing portion 32L. The more air in the tubingrelative to milk, the more the tube portion 32L will move for a givenforce thereagainst by compression member 38L or a given pressure change.This relationship can be mapped, for example, to provide a look up tableto identify the percentage of air and percentage of milk in the tube 32before purging. Then, knowing the volume that has been purged by knowingthe travel of the compression member 38 during the purge, the volume ofmilk and the volume of air can be calculated.

Further optionally, the opening of the valve 50 can be monitored or themovement of fluid past the valve 50 can be monitored. By knowing thecrack pressure of the valve 50 and knowing the pressure within thetubing 32, this can identify when a purge actually pushes through (i.e.,when pressure in tube 32 reaches the crack pressure). This can increasethe accuracy of the calculated purge volume by beginning the volumecalculation at the position of the compression member at the time thatthe crack pressure is reached.

In addition to calculating the volume of milk purged with each purgecycle, the system (via controller 52) can sum the volumes from all purgecycles to calculate the total volume pushed into the milk collectioncontainer 60 during a milk extraction session. This volume can be storedwith a unique identifier provided to the milk container so that thesystem 100 keeps a record of how much milk is stored in each milkcollection container 60. This information can also be time stamped sothat the user will know the time and date that milk was collected,regarding each milk collection container. Additional statistics can becalculated, including, but not limited to: average volume per extractionsession, total volume extracted for any given day, average milkextraction volume per day, etc. Any and all of this data can be exportedto an external computer, either manually, or it may be automaticallyuploaded to the computer 470 when the computer 470 is within range ofthe system 100 for wireless communication, or when the computer 470 isconnected to the system by wire. Further optionally, any or all of thisdata can be either manually or automatically uploaded to a cloud serviceover the Internet, either wirelessly or by wire.

When calculating milk volume pumped from the system 100, there is a needto distinguish between any air pumped by the system versus milk pumpedfrom the system, as well as pumping mixtures of milk and air. Wheninitiating a milk pumping/extraction session, there is air in the tubing32 this initial volume of air needs to be pumped into the milkcollection container 60 to prime the pumping system 100. Distinctionbetween pumping air versus pumping milk can be recognized by correlatingpressure changes with the amount of movement of compression member 38needed to establish the pressure changes. For example, when air is inthe tubing, a greater change in position, or more overall travel of thecompression member 38 is need to establish the same pressure change thanthat needed when the tubing 32 is filled with milk. Thus, relativelymore motion of the compression member with relatively less pressurechange indicates air in the tubing 32. This difference in pressure mayalso be detected when the compression member 36 is open (i.e., notclosing off tube portion 32S) and compression member 38 is retractingand this increasing the vacuum pressure.

FIGS. 31A-31B schematically illustrate breast pump systems 100,according to alternative embodiments of the present disclosure, in whichthe external shell 34 of the system does not need to be continuouslycurved, but, instead can have another shape, such as geometrical (all ora portion of which is non-curved) or even irregular or some other customshape designed to conserve space. In the embodiment of FIG. 31A, shell34 has substantially flat surfaces that form an angular externalsurface. These surfaces can more closely contour the internal componentsof the system than that provided by a continuously convex external shell34., and thereby eliminate spaces that are devoid of components in asystem with a continuously convex external shell 34. In the embodimentof FIG. 32B, external shell has a flat central portion, similar to theembodiment of FIG. 31A, but has convex portions extending radially fromthe flat central portion. It is noted that these are two non-limitingshapes provided, as the shape of external shell can take on almost anyshape that is well suited to receiving the internal components of thesystem 100, while eliminating as much void space as possible. Milkcollection container 60 is mountable over the external shell 34. Themilk collection container 60 can be formed so as to have variable volumewhen filled, so as to conform to the external surface of the externalshell, while providing a convex shape externally, so as to mimic theshape of the breast 2. As shown in FIG. 31A, the peripheral portions ofthe container 60 are thinner when filled than the central portion of thecontainer 60 when filled. In FIG. 31B, the container is pre-shaped tofollow the contours of the external shell 34 when filled, includingbulbous portions 34B that conform to the concave portions of theexternal shell 34. These solutions provide for a more compact overallsystem, while at the same time maintaining the appearance of the system100 when worn to resemble that of the natural breast. The externalsurface 60E of the milk collection bag 60 can be formed so as tomaintain a continuously convex appearance even when the milk collectionbag is empty. The milk collection bag 60 may have a rigid inner surfacethat mates with the contours of the external shell 34 and a soft,flexible external surface that inflates/moves as milk enters the bag 60,while maintaining a convex/naturally appearing breast shape.Alternatively, the exterior surface of the milk collection bag 60 may berigid to maintain breast/convex shape and the inner surface may be softand flexible to match the contours of the external shell 34, as the bag60 expands while it fills up with milk. Another option is for bothsurfaces to be rigid and yet allow some motion as the space/bladder inbetween fills with milk, allowing the surfaces to move apart as neededto accommodate the volume of milk received.

FIGS. 32A-32B illustrate a milk collection container 60 for use insystem 100 according to another embodiment of the present disclosure. Inthis embodiment, container 60 has a preformed convex surface 60C that isshaped to mimic the natural appearance of the breast 2. Surface 60 c maybe pre-formed such as by molding or the like, and maintains the convexshape shown, even when the container is empty, as well as when itcontains milk. When mounted on the system housing 34 the convex shape 30provides the appearance of a natural breast, with or without containmentby a bra. The opposite surface 60F of the container 60 is flexible andmay even contain wrinkles or folds 60W when container 60 is empty. Asthe container 60 fills with milk, the container 60 expands by moving theflexible surface outwardly. During the outward movement of the flexiblesurface 60W, the flexibility of this surface allows it to conform to theshape of the system housing/external shell 34 to maximize conservationof space of the entire system 100. FIG. 32A illustrates in dashed linesthe shape of the flexible surface 60W when is moved to contour to theexternal shell 34 of the embodiment of FIG. 31A. FIG. 32B illustrates indashed lines the shape of the flexible surface 60W when is moved tocontour to the external shell 34 of the embodiment of FIG. 31B.

In addition or alternative to the flexible surface provided 60F providedwith a pre-shaped surface 60C, milk collection container may be furtherbe provided with one or more structural elements, 76, such as baffles,heat seals, struts or other restrictions that restrict the amount ofexpansion of flexible surface 60F relative to contoured surface 60C andor provide shape to the collection container 60 even when empty. FIG. 33shows container 60 having baffles 76 that internally connect to theinternal walls of portions 60F, 60C to limit the amount of expansion inthe areas where the baffles 76 are located, relative to the amount ofexpansion that the remaining areas can experience. Baffles 76 can beprovided in any pattern desired so as to customize the expanded contoursof the flexible surface 60F to conform to a particular contour of anexternal shell 34.

FIG. 32C illustrates a milk collection container 60 that is formed sothat the distal surface 60D of the container, when filled with milk hasa shape that matches the proximal surface contour of the external shell34. The proximal surface 60C may be flexible or pre-formed with theconvex shape that mimics the appearance of the breast 2.

Even in embodiments of the breast pump system 100 wherein the externalshell is convex, the milk collection container 60 used therewith withhave varying levels of thickness from top to bottom and side to sidewhen milk is collected into the container 60 while mounted on thesystem. Accordingly the container 60 can be pre-shaped or preconfiguredto take on a shape having varying thicknesses between the rear and frontwalls when containing milk.

FIG. 34 illustrates a milk collection container 60 that includes apassive sensor 358 that can be either attached to or embedded in thecontainer 60. Sensor 358 may be an RFID or NFC device, or the like thatcontains a unique identifier (ID) is created in a manner that isrecognizable to controller 52 and/or external computer 470. Thecontroller 52 and/or external computer are provided with a readingapplication that can wirelessly read the unique ID when the container 60that includes the sensor 358 having the unique ID is brought into closeproximity with the controller 52, such as by mounting the collectioncontainer 60 to the external shell 34. Once read, this unique ID is thenreferenced by the controller 52 and/or external computer 470 into adatabase application that contains detailed information as to what thesensor 358 is attached to. Upon confirming the specific collectioncontainer that the sensor 358 is attached to/embedded in, the system 100can then track usages of that specific container, including, but nolimited to: volume of milk collected, date and time of collection,duration of extraction session, etc. Optionally, if a collectioncontainer 60 does not include a sensor 358 with a unique ID that isrecognizable to the system 100, then the system will not operate withthat collection container.

FIG. 35 illustrates a milk collection container 60 wherein the connector62 contains one-way valve 50, according to an embodiment of the presentdisclosure. With this embodiment, the external shell 34 or tubing 32would not be provided with the one-way valve 50, but would be providedwith a mating connector to connect to connector 62 containing theone-way valve. Whether one-way valve 50 is provided with the connector62/collection container 60 or provided at the end of tubing 32, themating connector for connecting to connector 62 can otherwise be thesame. Examples of mating connector arrangements can be found, forexample in Provisional Application Serial no. 62/027,685. Other examplesof connector types that can be used for connector 62 and matingconnector include, but are not limited to: bayonet-type, threadedconnectors, compression fittings, flared fittings, etc.

FIG. 36 illustrates a milk collection container 60 according to anotherembodiment of the present disclosure. In this embodiment, tubing 32 ismade integral with the milk collection container 60 and one-way valve 50as shown. The open end of tubing 32 is provided with a connector 62configured to mate with connector 134 of skin contact member 10.

When a user has completed the pumping phase of extracting milk from abreast 2, it is useful and efficient to purge as much milk that remainsin the tubing 32 from the tubing 32 and into the milk collectioncontainer 60. FIG. 38 illustrates events that may be carried out toperform a purge according to an embodiment of the present disclosure. Atevent 3802 the system 100 ends the pumping cycle having been carried outduring the extraction phase. Ending of the extraction phase can beperformed upon elapse of a predetermined extraction phase time,calculation of a predetermined amount of milk having been pumped, manualcessation of the extraction phase by the operator, or some otherpredetermined value having been achieved after performing theextraction. At event 3804 the direction of the pumping stroke ofcompression member 38 is reversed and the compression member 38 is runin the reverse direction to decrease suction within the tubing 32 andoptionally create a small positive pressure within the tubing 32 tofacilitate removal of the system 100 from the breast 2. Alternatively,the suction may be decreased to a level where a slight suction remainsso that the user still pulls the system 100 of the breast 2 to detachit. Preferably the vacuum is reduced to 0 mmHg, or a slightly positivepressure to automatically detach the system 100 from the breast 2. Theend pressure value where the pressure reduction by reverse pumping isceased can be in the range of about -20mmHG (weak vacuum) to a positive50 mmHg (e.g., the crack pressure of the valve 50). The compressionmember 36 does not close off the tubing portion 32S during this process,rather, tubing portion 32S remains open. Initiation of this reversepumping may occur automatically after executing event 3802 or,alternatively, may be initiated by the user actuating a purge actuatoron the optional control panel 166 provided on the system 100 (see FIG.23 ). This process continues until the seal of the system 100 to thebreast 2 is broken, which is detected by the controller 52 via sensor 54at event 3806. Once exposure of the tubing 32 to atmospheric pressure isdetected at event 3806, the stroke direction of pumping is againreversed thereby pumping the milk in tubing 32 under positive pressureand driving the milk from the tubing 32 into the container 60 at event3808. At event 3810 the purge process ends. Event 3810 can occur at somepredetermined time after initiation of event 3808, or can be initiatedby measuring the compliance of tubing portion 32L and executing event3808 when the compliance of tubing portion 32L indicates that thecontents in tubing portion 32L have a least a predetermined percentageof air therein (such as 90% 95%, 97% or some other predeterminedpercentage). If by chance, the system 100 accidentally or otherwisebecomes resealed to the breast 2 during purge pumping, the system 100can automatically shut down as it senses vacuum pressure beingregenerated in the vicinity of the breast 2/skin contact member 10.

FIGS. 39A-39B illustrate various arrangements that may be provided tothe system 100 to help prevent loss of milk out of the system upondetachment of the system 100 from the breast 2. These arrangements canbe provided in embodiments that are configured to execute a purgeoperation in a manner described with regard to FIG. 38 above, but canalso be provided in systems 100 that used different purge techniquesother than that described with regard to FIG. 38 .

A weak valve 390, such as a flap valve of the like can be provided insmall tube portion 32S, near where it connects to the skin contactmember 10, as illustrated in FIGS. 39A-39B. Valve 390 is very flexibleso that it opens in a first direction (upwardly as shown in FIGS.39A-39B) when vacuum is generated in tubing 32. A very small amount ofvacuum (much less than latch vacuum, for example about 5-15 mmHg) issufficient to open the valve 390 in the upward direction, see 390A. Thevalve 390 is sufficiently stiff to remain closed under a positivepressure equal to the hydrostatic pressure generated when the tubing 32is completely filled with milk. A positive pressure that is generatedwhich is above this hydrostatic pressure by a predetermined amount(e.g., 5-15 mmHg positive pressure greater than the positive pressuregenerated by a full column of milk) forces the valve 390 open in theopposite direction, see 390B (i.e., downwardly, as illustrated in FIGS.39A-39B). With this arrangement, the breast pump system 100 can beunsealed and detached from the breast 2 after extracting milk therefromand the milk remaining in the tubing 32 will be prevented from escapingout of the skin contact member 10 by the closed valve 390. The system100 can then be run in a forward stroke motion to generate positivepressure using compression member 38 to drive the milk from the tubing32 and into the milk collection container 60.

Additionally or alternatively, a valve or flap may be provided to extendradially inwardly from the bottom portion of the breast contact member122 as shown in FIG. 39A. When the breast 2 is inserted into the breastcontact member 122 for carrying out an extraction session, the breast 2folds down the flap/valve 522 against the inner wall of the breastcontact member 122, see 522-2, When the breast 2 is removed from thebreast contact member 122, the flap/valve 522 resiliently returns to isits unbiased position (see 522-1), where it extends radially inwardlyand thereby retains milk within the breast contact member 122 that wouldotherwise have spilled out of the system. By tipping the breast contactmember 122 up, the user can cause the milk in the breast contact member122 to flow into the nipple receiving portion 112 under gravity, whereit can be pumped into and through the tubing 32 to be purged into themilk collection container. Further alternatively, flap 522 may beprovided with a tacky surface that contacts the breast 2 so as to assistin providing tension to the breast 2 to control the amount of breasttissue that enters the nipple receiving portion 112, similar to thefunction of the tacky regions 360 described above. Further optionally oradditionally, the stiffness or strength of the valve/flap 522 can besuch that the breast contact member 10 has to be pressed against thebreast 2 to deflect the valve/flap 522, which thereby establishestension. Still further, flap 522 can be provide at both top and bottomlocations of the breast contact member 122 (rather than just at thebottom as shown in FIG. 39A), or at other locations intermediate the topand bottom, or could be formed continuously around the entire perimeterof the breast contact member 122.

FIGS. 40A-40B illustrate two different cross-sectional views of acontour element 410 provided with a breast pump system 100. Contourelement 410 extends distally from the distal perimeter 34D of theexternal shell 34 and proximally extends over the distal portion ofexternal shell 34 to provide a contoured extension of the external shellthat provides a visually more appealing appearance the more closelymimics the natural appearance of a breast 2 supported by a bra. Thecontour element 410 tapers distally to form a smoother transition withthe breast 2 when the system 100 is mounted on the breast 2, therebymaking the system 100 less visible or noticeable when worn by a user.The contour member 410 can be configured to snap around thecircumference of the main body 34 of system 100 or form a friction fittherewith, for example.

FIG. 40A shows a cross-sectional view illustrating the upper and lowerportions of the contour element 410. FIG. 40B shows that contour elementon the left and right sides of the external shell 34. The embodimentshown in FIG. 40B is for the right breast. A contour element for theleft breast would be a mirror image of that shown in FIG. 40B, as, inboth cases, the contour element 410 has a lateral portion 410A thatextends further distally from perimeter 34D than the distance thatmedial portion 410B extends distally from the perimeter 34D. The lateralportions of the systems 100 are contoured more by the contour element410 then are the medial portions, as the medial portions are where thecleavage of the breasts is formed, so deviation from the naturalappearance is less visible on the medial sides. Further, the medialextensions are less as there is less space to extend into. Additionally,the contour element 410 may extend over a portion of the proximal endportion of the external shell 34 to provide additional “flatness” to theproximal end of the system 100 to make it appear more like a naturalbreast 2 as opposed to a more pointy “ice cream scoop” shape, Althoughthe sections of component 410 in FIGS. 40A-40B are illustrated as solidmaterial in FIGS. 40A-40B, such as being made of foam, plastic, or otherlightweight material, they could alternatively be made hollow, or evenmade of one layer of material to provide the same contouring shapes.Thus a single thin layer of plastic or fabric could be alternativelyused, for example as illustrated in FIGS. 41A-41B. The material of thecontour element 410 may be resilient so that if it is depressed ordistorted, it will naturally spring back to a contour that appearsnatural.

Attachment members 412 such as snaps, hook-and-loop type fasteners,buttons, magnets or other attachment members may be provided on one, orpreferably more than on locations of the external shell 34 and internalsurface(s) of the contour element 410 to ensure securement of thecontour element 410 relative to the external shell, and to ensure thatthe proper orientation of the contour element 410 relative to theexternal shell 34 is achieved each time they are connected, so as toprovide the desired appearance,

FIG. 42 illustrates an embodiment of a contour element 410 fitted on anexternal shell 34 in which the external shell 34 is provided with a key34K that ensures that the contour element 410 is properly oriented onthe external shell 34 each time the two components are mated. Thecontour element 410 has a mating key 410K that mates with key 34K andensures that the contour element 410 position relative to the externalshell 34 does not rotationally vary nor does it vary superiorly,inferiorly, laterally or medially, but rather is positionedsubstantially exactly the same relative to the external shell 34 eachtime it is mounted thereover. As shown, the key 34K extends from thesurrounding surface of the external shell 34K and the mating key 410K isan opening in the contour element 410 that mates to the mating key 34K.Alternatively key 34K could be formed as a depression in the externalshell 34 and mating key 410K could be a ridge extending inwardly (or asolid shape extending inwardly) from the surrounding inner surface ofthe contour element 410 and shaped to mate with key 34K. It is furthernoted that the shapes of the key 34K and mating key 410 are not limitedto those shown, but could be any shape that ensures that the contourelement 410 can be mounted to the external shell 34 in one orientationand position. Further, the key 34K and mating key 410K do not need to becentrally located, but could be at any location on the external shell 34(and corresponding location of contour element 410). Also, multiple keys34K and mating keys 410K could be provided at multiple locations.

The contour element can be adjustable, so that it can be adjusted for abest fit relative to the breast 2, and so that it can be fitted todifferent sizes and shapes of breasts 2 and still provided a morenatural appearance in each case. FIG. 43 illustrates an embodiment ofcontour element in which a first edge 414 of the contour element 410overlaps a second edge 416, and can be adjusted to reduce, increase ormaintain the circumference of the distal perimeter 410D, while at thesame time reducing, increasing or maintaining the proximal perimeter410P. After adjustment, the first edge 414 can be fixed to theunderlying surface of the contour element 410 that it overlies, such asby use of hook-and-loop type fasteners, snaps, adhesive, or the like.The contour element can be further tailored for a better fit, if needed,but cutting away all or a portion of the distal perimeter 410D to alength desired, so as to adjust the length by which the contour element410 extends from the distal perimeter 34D on the top, bottom and sidesof the device. All of these distances can be tailored to be as needed.

FIG. 44 illustrates an embodiment of contouring element 410 providedwith predetermined markings that may be provided to assist the user inadjusting the contouring element 410 to better contour to the breast 2that it is to be used on. For example, markings 418, 420, 422 and 424can be provided as suggested starting locations for placement of theedge 414 overlapping edge 416 and placed at the appropriate marking forD cup, C cup, B cup and A cup sizing, respectively. Markings 426, 428and 430 are suggested locations to cut away the distal edge 410D to fit36″, 34‴ and 32″ breasts 2, respectively.

FIG. 45A illustrates an embodiment in which external shell 334 isprovided with two keys 34K1 and 34K2. The contour element of FIG. 45B isprovided with mating keys 410K1A and 410K2 that are configured to matewith keys 34K1 and 34K2, respectively, when the contour element 410 isin a first sizing configuration. Additional mating keys 410K1B and410K1C are provided to mate with key 34K1 when the contouring element410 is adjusted in a manner described above to better contour withsmaller size breasts 2. Although two additional mating keys 410K1 and410K2 are shown, more or fewer can be provided where more or lessadjustability is needed. Likewise, additional mating keys could beprovided for 410K2, in addition to, or alternative to the provision ofmultiple mating keys 410K1.

FIGS. 46A-46B illustrate a contour element 410 according to anotherembodiment of the present disclosure. In this embodiment, contourelement 410 is made of an easily compressible material such as a light,resilient foam that readily conforms to the shapes of objects that it iscompressed against. In the embodiment shown, the contour element 410 isa substantially straight plate-shaped element that tapers at its ends,but other shapes could be employed. The center portion of the contourelement 410 can be attached to the external shell 34 as shown in FIG.46A, using any of the connectors, adhesives or the like describedpreviously. When the system 100 is supported by a bra 440 as shown inFIG. 46B, the contour element 410 contours to the external shell 34 ofthe system, and also contours to the bra 440, thereby providing anatural breast shaped appearance. Further alternatively, the contourelement 410 of FIG. 46A could be made thinner and would not be requiredto contour to the external shell 34, as the bra 440 provides acontouring shape.

The system 100 can be configured to distinguish whether it has beenattached to the left breast 2 or the right breast 2 of the user. Thiscan be useful for tracking milk volume output per breast, per session,total daily volume per breast, etc. When using two of the pump systems,the tracking of data for each breast can still be maintained accurately,even when one of the pump systems 100 is attached to the left breastduring a current pumping session after having been attached to the rightbreast during a previous pumping session. In one embodiment, the pumpingsystems 100 can establish current location (i.e., left or right breast)by receiving a signal from the other pumping system having been attachedto the other breast 2. This established relative left-right locations ofthe two pumping systems 100, so that each system 100 can accuratelyrecord as to whether milk is being extracted from the right breast 2 orleft breast 2. This identification is automatic, without any user inputrequired and it also relieves the burden on the user to otherwise keeptrack of which pump system 100 is placed on each breast and to maintainthis order with each successive pumping session.

An orientation signal, such as by Wi-Fi, BLUETOOTH, BLUETOOTH Low Energy(BTLE), RFID, NFC or the like may be used to automatically determinewhich pump 100 is on which breast 2. One or more magnetic coils 450 mayoptionally be provided in each pump system 100 (e.g., see FIG. 23 ) suchthat the relative positions of the pump systems 100 can be determined toeach other by the signal, akin to the way that surgical tracking isperformed with coil magnetic sensors. By placing magnetic coils on theleft and right sides of the pump systems 100, and running a smallcurrent through the coil 450 in one of the pump systems 100, the currentinduces a signal in the coil 450 in the other pump system 100. Thesignal strength is low and is only induced when the breast pump systemsare close together, such as when mounted on adjacent breasts 2. Thissignal can be used to determine the relative locations of the pumpsystems 100, i.e., which system 100 is mounted on the left breast 2 andwhich system 100 is mounted on the right breast 2.

The system 100 can calculate the pressure during operation in any of themanners described above. The suction (pressure) level can be varied asdesired, and by continuously or repeatedly measuring/calculatingpressure, the feedback provided by sensor(s) 54 to controller 52provides a control loop that can be used to adjust the compressionmember 38 position and/or speed to vary the suction pressure to a leveldesired, or maintain a desired suction pressure. Thus, controller 52 cancontrol the positions and speeds of compression members 36, 38 toachieve any vacuum pressure pumping profile desired, and provideautomatic, real time adjustments to maintain a desired vacuum pressurewithin the system.

The controller 52 tracks the position of the compression member 38relative to the tubing 32L, such as by keeping track of the driver 46position or shaft position (interconnecting linkage between driver 46and compression member 38), and calculates (or looks up) pressure basedupon data received from sensor 54. Thus, changes in position and/orspeed of the compression member 38 by controller 52 can be controlled byresulting changes in pressure calculated or looked up, relative to thepressure sought to be achieved. Controller 52 can control compressionmember 36 in a similar manner, but control of member 36 is more focusedon position control, as the compression member 36 needs to fully closeoff tube portion 32S when maintaining latch suction against the breast2/nipple3. However, the closing off is timed and performed at thedetermined latch pressure, which is known from the data received fromsensor 54.

During extraction, the compression member 38 cycles between latchsuction and maximum suction to extract milk from the breast 2. Thesuction level of the maximum suction can optionally be adjusted to thecomfort of the user, anywhere between latch suction pressure to amaximally allowed suction pressure, such as -250 mmHg or some otherpredetermined maximally allowed suction pressure. As the tubing 32receives more and more milk volume, the compression member moves fartherand farther in the direction away from tube portion 32L toachieve/maintain maximum suction. As the compression member 38 begins tonear its position limit away from the tube portion 32L (near the fullyuncompressed state of tube portion 32L), the controller 52, knowing theposition of the compression member 38 at all times, controls the driver46 to purge the milk currently held in the large tube portion 32L, bydriving the compression member 38 to its opposite position limit (whereit compresses the large tube portion 32L the most). This reestablishes,or resets the compression member, so that it again can establish themaximum suction level without nearing its position limit. This processis repeated each time the compression member 38 comes within apredetermined distance from its position limit.

FIG. 47 illustrates events that may be carried out by the system 100during an extraction mode of pumping milk from a breast. At event 4702,after latch and let down of milk have been achieved, the system beginsoperating in extraction mode. In extraction mode, the system cyclesbetween latch suction (e.g., about 55 mmHg, or a value preselected fromthe range of about 25 mmHg to about 80 mmHg suction) and maximum suction(e.g., about 150 mmHg, or a value preselected from the range of about130 mmHg to about 200 mmHg suction). The pumping cycle may be a regular,continuous cycle, or may be pre-programmed to provide some irregularity,such as occasional pauses in pumping action to simulate when abreastfeeding baby pauses to take a break before resuming suckling. Thecycle speed of the pumping action is predetermined in the embodiment,such as 60 cycles per minute, or some other predetermined rate.Optionally, the operator may be able to set or adjust the cycle speed tobe used when initiating the extraction mode and/or at any time duringoperation in extraction mode. The controller 52 monitors the pressurewaves within the system 100 at event 4704 and the motion of thecompression member 38. If there has been no expression of milk, thepressure wave profile and the motion of the compression member 38 arefairly consistent, with little or no changes in end points of the travelof the compression member. As milk enters the system, the controllerwill need to move the compression member further to achieve the sametarget maximum vacuum level and this change in the pressure versuscompression member 38 position relationship is identified by thecontroller as an indicator that milk has entered the tubing 32. Whensubstantially no change in the pressure versus compression member 38position has occurred, pumping continues with the current pumping cycleparameters as to speed and movement of the compression member 38. Whenthe pressure versus compression member 38 position changes, such as dueto milk entering the system, the controller 52 at event 4704 identifiesthe change in the relationship between compression member 38 positionand vacuum pressure achieved, via feedback from sensor 54 and monitoringof the motor, gear train and/or compression member positions, andadjusts the speed, travel range and/or position of compression member 38at event 4708 in an effort to maintain the desired pressure profile,cycling between latch vacuum and maximum vacuum levels. If nopressure/position relationship change (within a predetermined minimalrange) is sensed at 4704, then the system continues pumping with thecurrent cycle control parameters at event 4706.

At event 4710 the controller checks to determine whether the outwardposition limit of the compression member 38 has been reached during theattempt to maintain the system operating according to the predeterminedpressure profile. If the position limit has been reached, then thecontroller 52 at event 4712 controls the system to perform a purgeprocedure by reducing the pressure to latch pressure; sealing off tubingportion 32S by compressing it with compression member 36, and operatingdriver 46 to drive the compression member 38 inwardly against the tubeportion 32L to the other position limit to purge the milk from the tubeportion 32L and then processing proceeds to event 4714. If the positionlimit has not been reached at event 4710 then processing proceedsdirectly to event 4714. At event 4714 the pressure is again checked tosee if predetermined pressure parameters have been achieved. If thepressure profile has been returned to target (the predetermined pressureprofile) then the controller checks to see whether processing shouldcontinue at event 4716. Optionally, event 4716 can be omitted and theextraction mode can be ended manually by the operator. Even when event4716 is adopted, the user can manually stop the extraction mode at anytime by actuating a manual switch on control panel 166. Extraction modepumping may automatically end after a predetermined time period, or whensome other event has been achieved. For example, flow of milk can becalculated based upon the pressure change calculations made by thecontroller, and total volume of milk extracted can also be calculated.Accordingly, extraction mode pumping can be ended after a predeterminedvolume of milk has been pumped, for example, or when the controller 52estimates that the milk flow has diminished below a predetermined flowrate for a determined amount of time. Further alternatively, the system100 can be automatically shut down after the controller 52 determinesthat a predetermined time period (e.g., one minute or some otherpredetermined time period) has elapsed during which there has been zeroflow of milk. Further alternatively, the system can be automaticallyshut down after the controller 52 has determined that a combination ofevents have occurred, e.g., after five minutes if flow is at zero for atleast one minute, or some other predetermined combined logic.

If extraction mode is to continue at event 4716, the processing proceedsto event 4704. If extraction mode is to end, then the process ends atevent 4718. If the predetermined pressure profile has not been achievedat event 4714, the processing proceeds to event 4708.

A build supply mode can be programmed into the system that can be usedby the user to help increase milk production. Using characteristics ofthe system 100, when in build supply mode, with a milk extraction volumegoal having been set, the system 100 will conduct the pumping sessionincluding the extraction mode as usual, but once the historical volumehas been achieved, the system 100 will continue pumping with pumpingcharacteristics that simulate a hungry, growing baby such as increasingthe maximum suction and holding that level for slightly longer during apumping cycle to simulate a baby trying to draw more milk out of thebreast 2, before shutting down.

In another embodiment, the predetermined pumping cycle speed of thesystem 100 in extraction mode can automatically increase according tothe age of the user’s baby. It has been found that the sucking frequencyof a newborn infant is slower than that of the same baby at six monthsold, for example. By tracking the age of the user’s baby, the controller52 can automatically scale the increase of the predetermined pumpingcycle speed to the age of the user’s baby. Thus, for example, when usingthe system 100 when the user’s baby is a newborn, the cycle speed mightbe 60 CPM (cycles per minute), and might be 65 CPM when the baby is twomonths old, and might be 70 CPM when the baby is six months old. Thesenumbers are only exemplary and the disclosure is not to be limited tothem, as the more general concept of automatically increasing thepredetermined cycling frequency based on age of the baby is what isdisclosed.

If the total volume of the tubing 32 and skin contact member 10 (minusthe volume occupied by the breast 2 and nipple 3) is represented as Tand the volume that is displaceable by compression member is representedas P, then P should be greater than 16.2% of T for purposes of thisdisclosure, i.e., P/T>0.162

FIG. 48 illustrates a nipple shield 480 according to an embodiment ofthe present disclosure. Nipple shield 480 can be attached to the breast2 as shown in FIG. 48 (such as by suction, reattachable adhesive, etc.)to cover the nipple 3 when the mother is breastfeeding her baby. One ofmore openings 482 are provided in the tip region of the nipple shield480 to allow the baby to draw milk through the nipple shield 480. Thetip portion 484 that overlies the nipple 3 and at least part of theareola 4 is made much thinner than the attachment portion 486 thatsurrounds the tip portion 484. For example, the nipple shield 480 may bemade of a single material, such as silicone, or other biocompatibleelastomer with similar elasticity properties, with the tip section beingabout 0.25 mm in thickness (or in the range of about 0.1 mm to about 1mm), while the attachment portion 486 may have a thickness in the rangeof about 2 mm to about 5 mm. This provides the attachment portion 486with more structural support and a better retention ability on thebreast 2, while the thinner tip portion 484 can easily expand, therebyproviding minimal resistance to the engorgement of the nipple 3 andareola 4, so as not to restrict the milk flow from the breast.

EXAMPLES

The following examples are put forth so as to provide those of ordinaryskill in the art with a complete disclosure and description of how tomake and use the present disclosure, and are not intended to limit thescope of what the inventors regard as their disclosure nor are theyintended to represent that the experiments below are all or the onlyexperiments performed. Efforts have been made to ensure accuracy withrespect to numbers used (e.g. amounts, forces, pressure, etc.) but someexperimental errors and deviations should be accounted for.

Example 1

Testing was done on a light body vinylpolysiloxane breast flange(Danville Star VPS #80011-01 (manufactured by Danville Materials inRamon, CA), to determine the relationship between force applied to thenipple receiving portion 494 and pressure (vacuum) within the nipplereceiving portion 494. The nipple receiving portion 494 was immobilizedby a support 496 and a predetermined force was applied by a load cell490 (see FIG. 49 to the nipple receiving portion 494 opposite thesupported side of the nipple receiving portion 494. A stopper 498 wasused to allow establishment of a vacuum within the nipple receivingportion 494 and a tube 502 was used to connect syringe 504 and pressuregauge 506 in fluid communication with the interior space of the nipplereceiving portion 494. Various runs were made with different preloadforces applied to the nipple receiving portion 494 by load cell 490,ranging from 1.5 N to 4 N, which corresponded to preload displacements(at atmospheric pressure) of the wall of the nipple receiving portionranging from -1.41 mm to -11.60 mm, see FIG. 50 . The pressure changesin the nipple receiving portion 494 generated by withdrawing the plungerof syringe 504 were measured by pressure gauge 506 and recorded andplotted relative to the forces on the nipple receiving portion measuredby the load cell 490.

FIG. 50 shows the plotted results, with the recorded data pointsinterconnected by best fit lines to show that the data shows asubstantially linear relationship between pressure (vacuum) 510 withinthe nipple receiving portion 494 and force 512 measure on the externalsurface of the nipple receiving portion 494. As the vacuum increased(pressure decreased), the force exerted by the nipple receiving portionon the load cell sensor 490 decreased according to a linearforce-pressure relationship.

Example 2

The arrangement of Example 1 was modified to test the dynamicforce-pressure relationship of the system. An oscilloscope 508 (see FIG.51 ) was electrically connected to receive output pressure reading andforce readings from pressure gauge 506 and load cell/sensor 490respectively. Like Example 1, preload displacements at atmosphericpressure were varied for different runs of the test, ranging from -11.60mm to -1.41 mm. For each run, the vacuum was cycled between high vacuumto low vacuum three times. For each run, the force exerted by the nipplereceiving portion on the sensor of load cell 490 was observed todecrease as the vacuum increased, according to a substantially linearforce-pressure relationship. FIG. 52 shows a plot of vacuum 512 andforce 514 plotted as voltage received by the oscilloscope 508 versustime, for the run with the preload displacement of -11.60 mm. It can beobserved that the force 514 decreases linearly proportionally to theincrease in vacuum 512 and vice versa. The same can be observed in FIG.53 , which plots vacuum 512 and force 514 as voltage received by theoscilloscope 508 versus time, for the run with the preload displacementof -1.41 mm. Similar results were observed for additional runs havinginitial displacements of -10.47 mm, -8.50 mm. -7.47 mm, -6.22 mm, -5.65mm, -3.54 mm, -4.69 mm and -2.44 mm, respectively. I

Example 3

The arrangement of Example 1 was modified to test the relationshipbetween the position of a target location of the nipple receivingportion 494 and vacuum level within the nipple receiving portion 494,see FIG. 54 . In this Example, the load cell 490 of Example 1 wasreplaced by a marker block 516 preloaded against the nipple receivingportion 494 with a spring 518 at atmospheric pressure. Upon pulling avacuum in the system by withdrawing the plunger of the syringe 504, themarker block 516 moves with the wall of the nipple receiving portion 494as it flexed inwardly due to the reduction in pressure.

Example 4

The arrangement of Example 1 was modified to test the relationshipbetween the position of a target location of the nipple receivingportion 494 and vacuum level within the nipple receiving portion 494,see FIG. 55 . In this Example, the load cell 490 of Example 1 wasreplaced by a first and second marker block 522, 524, connected by armsto a potentiometer 520, with the first marker block 522 being fixed to astationary reference location and the second marker block 524 beingfixed to the nipple receiving portion 494 and thus movable directly withmovements of the nipple receiving portion. The second marker 524 waspreloaded against the nipple receiving portion 494 at atmosphericpressure. Upon pulling a vacuum in the system by withdrawing the plungerof the syringe 504, the marker block 524 moves with the wall of thenipple receiving portion 494, relative to the fixed marker block 522, asthe nipple receiving portion 494 is flexed inwardly due to the reductionin pressure. The movement of marker 524 angularly moves the arm 526relative to arm 528 and this angular movement was registered by thepotentiometer and sent to oscilloscope 508. The change in angle 530 wasmeasured by the potentiometer, and the linear change in the distance 532between the position of marker 524 and marker 522, can be calculated bya difference in the original distance 532 and the distance correspondingto the angle calculated from the angle change measured, relative to theoriginal angle.

While the present disclosure has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of thedisclosure. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentdisclosure. All such modifications are intended to be within the scopeof the present disclosure.

That which is claimed is:
 1. A wearable, portable self-powered breastpump system for pumping milk from a breast, comprising: a pumpingmechanism; a fluid container configured to directly engage and fitwithin a bra wherein the fluid container is connected to a suction flowpath; and a flange configured to receive the breast, the flangeincluding a nipple receiving portion and a bottom portion, the bottomportion configured below the nipple receiving portion during use, thenipple receiving portion including a proximal end defining an opening;wherein the pumping mechanism is associated with the nipple receivingportion and the pumping mechanism is fixed above the nipple receivingportion to create a suction force from the nipple receiving portion, thesuction force and the suction path both being above the bottom portionof the flange.
 2. The breast pump system of claim 1, wherein the breastpump defines a generally breast shaped profile.
 3. The breast pumpsystem of claim 2, wherein the fluid container forms a part of thegenerally breast shaped profile.
 4. The breast pump system of claim 1,further comprising a controller.
 5. The breast pump system of claim 4,further comprising a sensor in communication with the controller toprovide a control loop that is used to adjust suction pressure.
 6. Thebreast pump system of claim 5, wherein the pumping mechanism includes aflexible member that creates the suction pressure, wherein the controlloop is used to adjust a speed of the flexible member to vary ormaintain suction pressure.
 7. The breast pump system of claim 5, whereinthe pumping mechanism includes a flexible member that creates thesuction pressure, wherein the control loop is used to adjust a positionof the flexible member to vary or maintain suction pressure.
 8. Thebreast pump system of claim 7, wherein a volume of the milk pumped iscalculated by assessing the position of the flexible member.
 9. Thebreast pump system of claim 8, wherein pressure changes are assessed bya comparison with positions of the flexible member.
 10. The breast pumpsystem of claim 7, wherein the pumping mechanism includes a secondflexible member, wherein the control loop is used to adjust a positionof the second flexible member to vary or maintain the suction pressure.11. The breast pump system of claim 7, wherein the pumping mechanismincludes a second flexible member, wherein the control loop is used toadjust a speed of the second flexible member to vary or maintain thesuction pressure.
 12. The breast pump system of claim 1, wherein avolume of milk pumped is calculated by comparing pressure changes.
 13. Awearable, portable self-powered breast pump system for pumping milk froma breast and sized and shaped to fit within a bra, comprising: a vacuumpumping flexible member configured to pump the milk from the breast; askin contact member configured to contact and form a seal with thebreast, the skin contact member including a nipple receiving portion; amilk collection container having a rigid exterior surface configured tocontact the bra; and a conduit suction path below the vacuum pumpingflexible member and above the nipple receiving portion wherein thevacuum pumping flexible member is above the nipple receiving portion tocreate upward suction.
 14. The breast pump system of claim 13, whereinthe breast pump system includes a letdown mode and an extraction mode.15. The breast pump system of claim 14, further comprising a controller,the controller configured to change a vacuum level in the breast pumpsystem to the extraction mode after the milk entering the breast pumpsystem.
 16. The breast pump system of claim 14, further comprising acontroller, the controller configured to change a pumping magnitude upona predetermined time.
 17. The breast pump system of claim 13, whereinthe breast pump system defines a generally breast shape.
 18. The breastpump system of claim 17, wherein the collection container forms part ofthe generally breast shape of the breast pump system.
 19. The breastpump system of claim 18, wherein the collection container has a valve.